Drug Information
The Drug Information Center has a wealth of information to help you understand how drugs impact your health as well as their place in today's healthcare environment.
The information you'll find in the center covers a number of important topics ranging from drug safety and side effects to medication costs and errors. You'll also notice from time to time we will display drug alerts. These alerts will let
you know when a New Drug is put on the market, if a drug has been recalled, and if a drug has a new indication or use.
Drug Name | Drug Reason | Date |
---|---|---|
Livmarli
The Food and Drug Administration (FDA)
expanded approval of Livmarli® (maralixibat oral
solution) to include the treatment of cholestatic
pruritus in individuals as young as 3 months old with
Alagille syndrome. Source: FDA website
|
Expanded Indication | 3/13/2023 |
Evkeeza
The Food and Drug Administration (FDA)
expanded approval of Evkeeza® (evinacumab-dgnb
injection) to include children ages 5 to 11 years for
the treatment of homozygous familial
hypercholesterolemia. Source: FDA website
|
Expanded Indication | 3/21/2023 |
Mekinist with Tafinlar
The Food and Drug Administration (FDA)
approved Mekinist® (trametinib tablets and oral
solution) with Tafinlar® (dabrafenib capsules and oral
solution) for pediatric individuals 1 year of age and
older with low-grade glioma (LGG) with a BRAF V600E
mutation who require systemic therapy. Source: FDA
website
|
New Indication | 3/16/2023 |
Daybue
The Food and Drug Administration (FDA)
approved Daybue™ (trofinetide oral solution) for the
treatment of Rett syndrome in adults and children 2
years of age and older. Source: FDA website
|
New Drug | 3/10/2023 |
Zynyz
The Food and Drug Administration (FDA)
approved Zynyz™ (retifanlimab-dlwr injection) for the
treatment of adults with metastatic or recurrent locally
advanced Merkel cell carcinoma. Source: FDA website
|
New Drug | 3/22/2023 |
Rezzayo
The Food and Drug Administration (FDA)
approved Rezzayo™ (rezafungin injection) for individuals
18 years or older who have limited or no alternative
options for the treatment of candidemia and invasive
candidiasis. Source: FDA website
|
New Drug | 3/22/2023 |
Dabigatran etexilate
Ascend Laboratories announced a
voluntary recall of dabigatran etexilate 75 mg and 150
mg capsules due to the presence of
N-nitrosodimethylamine (NDMA) impurity. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascend-laboratories-llc-issues-voluntary-nationwide-recall-dabigatran-etexilate-capsules-usp-75-mg
Source: FDA website
|
Drug Recall | 3/23/2023 |
Trikafta
The Food and Drug Administration (FDA)
approved Trikafta® (elexacaftor/tezacaftor/ivacaftor
tablets and oral granules) to include children with
cystic fibrosis (CF) ages 2 through 5 years who have at
least one F508del mutation in the cystic fibrosis
transmembrane conductance regulator (CFTR) gene or a
mutation in the CFTR gene that is responsive to Trikafta
based on in vitro data. Source: FDA website
|
Expanded Indication | 4/26/2023 |
Prevnar 20
The Food and Drug Administration (FDA)
approved Prevnar 20TM (20-valent pneumococcal conjugate
vaccine injection) for the prevention of invasive
pneumococcal disease (IPD) caused by the 20
Streptococcus pneumoniae (pneumococcal) serotypes
contained in the vaccine in infants and children six
weeks through 17 years of age, and for the prevention of
otitis media in infants six weeks through five years of
age caused by the original seven serotypes contained in
Prevnar. Source: FDA website
|
Expanded Indication | 4/27/2023 |
Sogroya
The Food and Drug Administration (FDA)
approved Sogroya® (somapacitan-beco subcutaneous
injection) for the treatment of pediatric individuals
who have growth failure due to inadequate secretion of
endogenous growth hormone (GH). Source: FDA website
|
Expanded Indication | 4/28/2023 |
Liqrev
The Food and Drug Administration (FDA)
approved Liqrev® (sildenafil oral suspension) for the
treatment of pulmonary arterial hypertension (WHO Group
1) in adults to improve exercise ability and delay
clinical worsening. Source: FDA website
|
New Formulation | 4/28/2023 |
Lumryz
The Food and Drug Administration (FDA)
approved Lumryz™ (sodium oxybate extended-release oral
suspension) for the treatment of cataplexy or excessive
daytime sleepiness (EDS) in adults with narcolepsy.
Source: FDA website
|
New Formulation | 5/1/2023 |
Uzedy
The Food and Drug Administration (FDA)
approved Uzedy™ (risperidone extended-release injectable
suspension for subcutaneous use) for the treatment of
schizophrenia in adults. Source: FDA website
|
New Formulation | 4/28/2023 |
Abilify Asimtufii
The Food and Drug Administration (FDA)
approved Abilify Asimtufii® (aripiprazole
extended-release injectable suspension)for the treatment
of schizophrenia in adults and as maintenance
monotherapy treatment of bipolar I disorder in adults.
Source: FDA website
|
New Formulation | 4/28/2023 |
Zejula
The Food and Drug Administration (FDA)
approved Zejula™ (niraparib tablets) maintenance
treatment of adults with advanced epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in
a complete or partial response to first-line
platinum-based chemotherapy and for maintenance
treatment of adults with deleterious or suspected
deleterious germline BRCA-mutated recurrent epithelial
ovarian, fallopian tube, or primary peritoneal cancer
who are in a complete or partial response to
platinum-based chemotherapy. Source: FDA website
|
New Formulation | 4/26/2023 |
Qalsody
The Food and Drug Administration (FDA)
approved Qalsody™ (tofersen injection for intrathecal
use) for the treatment of amyotrophic lateral sclerosis
(ALS) in adults who have a mutation in the superoxide
dismutase 1 (SOD1) gene. Source: FDA website
|
New Drug | 4/25/2023 |
Vowst
The Food and Drug Administration (FDA)
approved Vowst™ (fecal microbiota spores, live-brpk
capsules) to prevent the recurrence of Clostridioides
difficile infection (CDI) in individuals 18 years of age
and older following antibacterial treatment for
recurrent CDI. Source: FDA website
|
New Drug | 4/26/2023 |
Arexvy
The Food and Drug Administration (FDA)
approved Arexvy (respiratory syncytial virus vaccine,
adjuvanted injection) for the prevention of lower
respiratory tract disease (LRTD) caused by respiratory
syncytial virus (RSV) in individuals 60 years of age and
older. Source: FDA website
|
New Drug | 5/3/2023 |
Arexvy
The Food and Drug Administration (FDA)
approved Arexvy (adjuvanted respiratory syncytial virus
vaccine injection) for the prevention of lower
respiratory tract disease caused by respiratory
syncytial virus (RSV) to include those aged 50-59 years
who are considered to be at high risk of RSV infection.
Source: FDA website
|
Expanded Indication | 6/7/2024 |
Augtyro
The Food and Drug Administration (FDA)
approved AugtyroTM (repotrectinib capsules) for adult
and pediatric individuals 12 years and older with solid
tumors that have a neurotrophic tyrosine receptor kinase
(NTRK) gene fusion, are locally advanced or metastatic
or where surgical resection is likely to result in
severe morbidity, and that have progressed following
treatment or have no satisfactory alternative therapy.
Source: FDA website
|
New Indication | 6/13/2024 |
Akorn Operating Company
Akorn Operating Company announced a
voluntary recall of various within-expiry human and
animal products due to company closure. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/akorn-issues-voluntary-nationwide-recall-various-human-and-animal-drug-products-within-expiry-due
Source: FDA website
|
Drug Recall | 4/26/2023 |
Fentanyl Buccal Tablets
Teva Pharmaceuticals announced a
voluntary recall of specific lots of various strengths
of fentanyl buccal tablets due to a labeling error.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-initiates-voluntary-nationwide-recall-specific-lots-fentanyl-buccal-tablets-cii-due-labeling
Source: FDA website
|
Drug Recall | 4/27/2023 |
Kalydeco
The Food and Drug Administration (FDA)
approved Kalydeco® (ivacaftor tablets and oral granules)
for use in children with cystic fibrosis (CF) ages 1
month to less than four months old who have at least one
mutation in their cystic fibrosis transmembrane
conductance regulator (CFTR) gene that is responsive to
Kalydeco based on clinical and/or in vitro assay data.
Source: FDA website
|
Expanded Indication | 5/3/2023 |
Farxiga
The Food and Drug Administration (FDA)
approved Farxiga® (dapagliflozin tablets) to reduce the
risk of cardiovascular death, hospitalization for heart
failure and urgent heart failure visit in adults with
heart failure (previously for adults with heart failure
and reduced ejection fraction). Source: FDA website
|
Expanded Indication | 5/8/2023 |
Farxiga
The Food and Drug Administration (FDA)
approved Farxiga® (dapagliflozin tablets) for the
treatment of pediatric individuals aged 10 years and
above with type-2 diabetes (T2D). Source: FDA website
|
Expanded Indication | 6/12/2024 |
Rexulti
The Food and Drug Administration (FDA)
approved Rexulti® (brexpiprazole tablets) for use in the
treatment of agitation associated with dementia due to
Alzheimer’s disease. Source: FDA website
|
New Indication | 5/10/2023 |
Zolpidem
The Food and Drug Administration (FDA)
approved Zolpidem tartrate capsules for the short-term
treatment of transient insomnia characterized by
difficulties with sleep initiation in adults younger
than age 65 years of age. Source: FDA website
|
New Formulation | 5/9/2023 |
Motpoly XR
The Food and Drug Administration (FDA)
approved Motpoly XR (lacosamide extended-release
capsules) for the treatment of partial-onset seizures in
adults and in pediatric individuals weighing at least 50
kg. Source: FDA website
|
New Formulation | 5/4/2023 |
Motpoly XR
The Food and Drug Administration (FDA)
approved Motpoly XRTM (lacosamide extended-release
capsules) for the treatment of primary generalized
tonic-clonic seizures in adults and in pediatric
individuals weighing at least 50 kg. Source: FDA website
|
New Indication | 6/7/2024 |
Elfabrio
The Food and Drug Administration (FDA)
approved Elfabrio® (pegunigalsidase alfa-iwxj injection)
for the treatment of adults with confirmed Fabry
disease. Source: FDA website
|
New Drug | 5/9/2023 |
Mirena
The Food and Drug Administration (FDA)
approved Mirena® (levonorgestrel intrauterine device)
for duration of use up to 8 years for the prevention of
pregnancy. Source: FDA website
|
Expanded Indication | 08-12-22 |
Injectafer
The Food and Drug Administration (FDA)
approved Injectafer® (ferric carboxymaltose injection)
for the treatment of iron deficiency in adults with
heart failure and New York Heart Association Class
II/III to improve exercise capacity. Source: FDA website
|
New Indication | 5/31/2023 |
Lynparza
The Food and Drug Administration (FDA)
approved Lynparza® (olaparib tablets) in combination
with abiraterone and prednisone (or prednisolone) for
adults with deleterious or suspected deleterious
BRCA-mutated (BRCAm) metastatic castration-resistant
prostate cancer (mCRPC), as determined by a Food and
Drug Administration (FDA)-approved companion diagnostic
test. Source: FDA website
|
New Indication | 5/31/2023 |
Prevymis
The Food and Drug Administration (FDA)
approved Prevymis™ (letermovir tablets and injection for
intravenous use) for prophylaxis of cytomegalovirus
(CMV) disease in adult kidney transplant recipients at
high risk (Donor CMV seropositive/Recipient
CMV-seronegative [D+/R-]). Source: FDA website
|
New Indication | 6/5/2023 |
Vevye
The Food and Drug Administration (FDA)
approved Vevye (cyclosporine ophthalmic solution) for
the treatment of the signs and symptoms of dry eye
disease. Source: FDA website
|
New Formulation | 5/30/2023 |
Inpefa
The Food and Drug Administration (FDA)
approved Inpefa™ (sotagliflozin tablets) to reduce the
risk of cardiovascular death, hospitalization for heart
failure, and urgent heart failure visit in adults with
heart failure or type 2 diabetes mellitus, chronic
kidney disease, and other cardiovascular risk factors.
Source: FDA website
|
New Drug | 5/26/2023 |
Abrysvo
The Food and Drug Administration (FDA)
approved Abrysvo™ (respiratory syncytial virus vaccine
injection) for the prevention of lower respiratory tract
disease caused by RSV in individuals 60 years and older.
Source: FDA website
|
New Drug | 5/31/2023 |
Compounded Semaglutide
The Food and Drug Administration (FDA)
communicated about medications containing semaglutide
marketed for type 2 diabetes or weight loss. There are
currently three FDA-approved semaglutide products which
are only available with a prescription. Due to two of
the drugs being in shortage, these are able to be
compounded if they meet certain requirements. The FDA
has received adverse event reports after people used
compounded semaglutide. The FDA has also received
reports that in some cases, compounders may be using
salt forms of semaglutide, including semaglutide sodium
and semaglutide acetate, which have not been shown to be
safe or effective. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss
Source: FDA website
|
Drug Warning | 5/31/2023 |
Qulipta
The Food and Drug Administration (FDA)
approved Qulipta™ (atogepant tablet) for the
preventative treatment of chronic migraines in adults.
Source: FDA website
|
Expanded Indication | 4/17/2023 |
Coagadex
The Food and Drug Administration (FDA)
approved Coagadex® (human coagulation factor X
injection) to include perioperative management of
bleeding in individuals with severe hereditary Factor X
deficiency. Source: FDA website
|
Expanded Indication | 4/14/2023 |
Polivy
The Food and Drug Administration (FDA)
approved Polivy® (polatuzumab vedotin-piiq injection) in
combination with rituximab, cyclophosphamide,
doxorubicin and prednisone (R-CHP) for the treatment of
adults who have previously untreated diffuse large
B-cell lymphoma (DLBCL), not otherwise specified (NOS)
or high-grade B-cell lymphoma (HGBL) and who have an
International Prognostic Index (IPI) score of two or
greater. Source: FDA website
|
Expanded Indication | 4/19/2023 |
Lupron Depot-Ped
The Food and Drug Administration (FDA)
approved Lupron Depot-Ped® (leuprolide acetate
injection) 45 mg single-dose, prefilled syringe for
6-month dosing regimen for the treatment of central
precocious puberty in pediatrics. Source: FDA website
|
New Formulation | 4/14/2023 |
RizaFilm
The Food and Drug Administration (FDA)
approved RizaFilm® (rizatriptan oral film) for the
treatment of acute migraine with or without aura in
adults and pediatric individuals 12 to 17 years of age
weighing 40 kg or more. Source: FDA website
|
New Formulation | 4/14/2023 |
Opioid Pain Medicines
The Food and Drug Administration (FDA)
is requiring several updates to the prescribing
information for immediate-release (IR) and
extended-release/long-acting (ER/LA) opioid pain
medicines. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/all-opioid-pain-medicines-drug-safety-communication-fda-updates-prescribing-information-provide
Source: FDA website
|
Drug Warning | 4/13/2023 |
Kevzara
The Food and Drug Administration (FDA)
approved Kevzara® (sarilumab injection) for the
treatment of polymyalgia rheumatica (PMR), an
inflammatory rheumatic disease, in adults who have had
an inadequate response to corticosteroids or who cannot
tolerate corticosteroid taper. Source: FDA website
|
New Indication | 2/28/2023 |
Kevzara
The Food and Drug Administration (FDA)
approved Kevzara® (sarilumab injection) for the
treatment of individuals weighing 63 kg or more with
active polyarticular juvenile idiopathic arthritis
(pJIA). Source: FDA website
|
New Indication | 6/10/2024 |
Verzenio
The Food and Drug Administration (FDA)
expanded approval of Verzenio® (abemaciclib tablets) for
the adjuvant treatment of adults with hormone
receptor-positive, human epidermal growth factor
receptor 2-negative, node-positive, early breast cancer
at high risk for recurrence. This approval also expands
the indication by removing the Ki-67 testing requirement
to identify high-risk patients. Source: FDA website
|
Expanded Indication | 3/3/2023 |
Naloxone hydrochloride
The Food and Drug Administration (FDA)
approved Naloxone hydrochloride 4 mg nasal spray for the
emergency treatment of known or suspected opioid
overdose, as manifested by respiratory and/or central
nervous system depression for adult and pediatric
individuals. Source: FDA website
|
New Formulation | 3/7/2023 |
Combogesic
The Food and Drug Administration (FDA)
approved Combogesic® (acetaminophen/ibuprofen tablets)
for the short-term management of mild to moderate acute
pain. Source: FDA website
|
New Formulation | 3/1/2023 |
Skyclarys
The Food and Drug Administration (FDA)
approved Skyclarys™ (omaveloxolone capsules) for the
treatment of Friedreich’s ataxia in adults and
adolescents aged 16 years and older. Source: FDA website
|
New Drug | 2/28/2023 |
Zavzpret
The Food and Drug Administration (FDA)
approved Zavzpret™ (zavegepant nasal spray) for the
acute treatment of migraine with or without aura in
adults. Source: FDA website
|
New Drug | 3/9/2023 |
Brimonidine tartrate
Apotex announced a voluntary recall
for six lots of brimonidine tartrate ophthalmic solution
due to cracks that have developed in some caps of
solution bottles. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-brimonidine-tartrate-ophthalmic-solution-015-due
Source: FDA website
|
Drug Recall | 3/3/2023 |
Opdivo
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab injection) to include the
pediatric population for the adjuvant treatment of adult
and pediatric individuals 12 years and older with
melanoma with involvement of lymph nodes or metastatic
disease who have undergone complete resection. Source:
FDA website
|
Expanded Indication | 2/15/2023 |
Yervoy
The Food and Drug Administration (FDA)
approved Yervoy® (ipilimumab injection) to include the
pediatric population for the treatment of unresectable
or metastatic melanoma in adult and pediatric
individuals 12 years and older. Source: FDA website
|
Expanded Indication | 2/15/2023 |
Austedo XR
The Food and Drug Administration (FDA)
approved Austedo® XR (deutetrabenazine extended-release
tablets) in adults for tardive dyskinesia (TD) and
chorea associated with Huntington’s disease (HD).
Source: FDA website
|
New Formulation | 2/17/2023 |
Lamzede
The Food and Drug Administration (FDA)
approved Lamzede® (velmanase alfa-tycv) for the
treatment of non-central nervous system manifestations
of alpha-mannosidosis (AM) in adult and pediatric
individuals. Source: FDA website
|
New Drug | 2/16/2023 |
Filspari
The Food and Drug Administration (FDA)
approved Filspari™ (sparsentan tablets) to reduce
proteinuria in adults with primary immunoglobulin A
nephropathy (IgAN) at risk of rapid disease progression,
generally a urine protein-to-creatinine ratio (UPCR)
≥1.5 g/g. Source: FDA website
|
New Drug | 2/17/2023 |
Syfovre
The Food and Drug Administration (FDA)
approved Syfovre™ (pegcetacoplan intravitreal injection)
for the treatment of geographic atrophy (GA) secondary
to age-related macular degeneration. Source: FDA website
|
New Drug | 2/17/2023 |
Altuviiio
The Food and Drug Administration (FDA)
approved Altuviiio™ (antihemophilic factor
[recombinant], Fc-VWF-XTEN fusion protein-ehtl],
lyophilized powder for solution, for intravenous use)
for use in adults and children with hemophilia A
(congenital factor VIII deficiency) for routine
prophylaxis to reduce the frequency of bleeding
episodes, on-demand treatment and control of bleeding
episodes, and perioperative management of bleeding.
Source: FDA website
|
New Drug | 2/22/2023 |
Descovy
The Food and Drug Administration (FDA)
approved Descovy® (emtricitabine/tenofovir alafenamide
fumarate tablets) to include treatment of human
immunodeficiency virus (HIV)-1 infection in pediatric
individuals at least 2 years of age and weighing at
least 14 kg.Source: FDA website
|
Expanded Indication | 01-07-22 |
Quviviq
The Food and Drug Administration (FDA)
approved Quviviq (daridorexant tablets) for the
treatment of adults with insomnia characterized by
difficulties with sleep onset and/or sleep
maintenance.Source: FDA website
|
New Drug | 01-07-22 |
Senna
Lohxa announced a voluntary recall of
one lot of Senna Syrup 8.8 mg/5 mL unit-dose cups due to
microbial contamination. Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lohxa-llc-issues-voluntary-nationwide-recall-senna-syrup-88mg5ml-due-microbial-contamination
Source: FDA website
|
Drug Recall | 01-13-22 |
Metformin
Viona Pharmaceuticals announced a
voluntary recall of twenty-three lots of metformin
hydrochloride extended-release tablets 750 mg due to
detection of N-nitrosamine (NDMA) impurity. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0
Source: FDA website
|
Drug Recall | 01-12-22 |
Buprenorphine
The Food and Drug Administration
(FDA) is warning that dental problems (tooth decay,
cavities, oral infection, and loss of teeth) have been
reported with medicines containing buprenorphine that
are dissolved in the mouth for opioid use disorder and
pain. The FDA is requiring a new warning be added to the
prescribing information. Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/buprenorphine-drug-safety-communication-fda-warns-about-dental-problems-buprenorphine-medicines
Source: FDA website
|
Drug Warning | 01-12-22 |
Rinvoq
The Food and Drug Administration (FDA)
approved Rinvoq® (upadacitinib tablets) for the
treatment of adults and children 12 years of age and
older with refractory, moderate-to-severe atopic
dermatitis (AD) whose disease is not adequately
controlled with other systemic drug products, including
biologics, or when use of those therapies is
inadvisable. Source: FDA website
|
New Indication | 01-14-22 |
Skyrizi
The Food and Drug Administration (FDA)
approved SkyriziTM (risankizumab-rzaa injection) for the
treatment of adults with active psoriatic arthritis
(PsA). Source: FDA website
|
New Indication | 01-24-22 |
Veklury
The Food and Drug Administration (FDA)
approved Veklury® (remdesivir injection) for the
treatment of coronavirus disease 2019 (COVID-19) in
adults and pediatric individuals (12 years of age and
older and weighing at least 40 kg) with positive results
of direct severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2) viral testing, who are not hospitalized
and have mild-to-moderate COVID-19, and are at high risk
for progression to severe COVID-19, including
hospitalization or death. Source: FDA website
|
Expanded Indication | 01-21-22 |
Ryaltris
The Food and Drug Administration (FDA)
approved RyaltrisTM (olopatadine
hydrochloride/mometasone furoate nasal spray) for the
treatment of symptoms of seasonal allergic rhinitis in
adults and pediatric individuals 12 years of age and
older. Source: FDA website
|
New Formulation | 01-13-22 |
Cibinqo
The Food and Drug Administration (FDA)
approved CibinqoTM (abrocitinib tablets) for the
treatment of adults with refractory, moderate-to-severe
atopic dermatitis (AD) whose disease is not adequately
controlled with other systemic drug products, including
biologics, or when use of those therapies is
inadvisable. Source: FDA website
|
New Drug | 01-14-22 |
Semglee
Mylan Pharmaceuticals announced a
voluntary recall of one batch of its non-interchangeable
Semglee injection due to the potential for a missing
label. Contact your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-recall-one-batch-semgleer-insulin
Source: FDA website
|
Drug Recall | 01-19-22 |
Solosec
The Food and Drug Administration (FDA)
approved Solosec® (secnidazole oral granules) for the
treatment of bacterial vaginosis and trichomoniasis
caused by Trichomonas vaginalis in individuals 12 years
of age and older. Source: FDA website
|
Expanded Indication | 01-26-22 |
Pifeltro
The Food and Drug Administration
(FDA) approved Pifeltro® (doravirine tablets) for the
treatment of human immunodeficiency virus (HIV)-1 in
pediatric individuals weighing at least 35 kg. Source:
FDA website
|
Expanded Indication | 01-27-22 |
Delstrigo
The Food and Drug Administration (FDA)
approved DelstrigoTM (doravirine/lamivudine/tenofovir
disoproxil fumarate tablets) for the treatment of human
immunodeficiency virus (HIV)-1 in pediatric individuals
weighing at least 35 kg. Source: FDA website
|
Expanded Indication | 01-27-22 |
Vonvendi
The Food and Drug Administration (FDA)
approved Vonvendi® (recombinant von Willebrand factor
injection) for routine prophylaxis to reduce the
frequency of bleeding episodes in individuals with
severe Type 3 von Willebrand disease (VWD) receiving
on-demand therapy. Source: FDA website
|
Expanded Indication | 01-31-22 |
Nucala
The Food and Drug Administration (FDA)
approved Nucala (mepolizumab 40 mg prefilled syringe
injection) as add-on maintenance treatment for children
6 to 11 years of age with severe asthma and with an
eosinophilic phenotype. Source: FDA website
|
New Formulation | 01-22-22 |
Kimmtrak
The Food and Drug Administration (FDA)
approved Kimmtrak® (tebentafusp-tebn injection) for the
treatment of human leukocyte antigen
(HLA)-A*02:01-positive adults with unresectable or
metastatic uveal melanoma (mUM). Source: FDA website
|
New Drug | 01-26-22 |
Vabysmo
The Food and Drug Administration (FDA)
approved VabysmoTM (faricimab-svoa injection for
intravitreal use) for the treatment of adults with
neovascular age-related macular degeneration (nAMD) or
diabetic macular edema (DME). Source: FDA website
|
New Drug | 01-28-22 |
Polymyxin B
AuroMedics Pharma announced a
voluntary recall of one lot of polymyxin B for injection
due to a product complaint for the presence of
particulate matter. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/auromedics-pharma-llc-issues-voluntary-nationwide-recall-polymyxin-b-injection-usp-500000-unit-vial
Source: FDA website
|
Drug Recall | 01-28-22 |
Xigduo XR
The Food and Drug Administration (FDA)
approved Xigduo® XR (dapagliflozin/metformin
hydrochloride extended-release tablets) to reduce the
risk of cardiovascular death and hospitalization for
heart failure in adults with heart failure (NYHA class
II-IV) with reduced ejection fraction. Source: FDA
website
|
New Indication | 02-03-22 |
Fleqsuvy
The Food and Drug Administration
(FDA) approved FleqsuvyTM (baclofen oral suspension) for
the treatment of spasticity resulting from multiple
sclerosis (MS), particularly for the relief of flexor
spasms and concomitant pain, clonus, and muscular
rigidity. Source: FDA website
|
New Formulation | 02-04-22 |
Enjaymo
The Food and Drug Administration (FDA)
approved EnjaymoTM (sutimlimab-jome injection) to
decrease the need for red blood cell (RBC) transfusion
due to hemolysis in adults with cold agglutinin disease
(CAD). Source: FDA website
|
New Drug | 02-04-22 |
Ukoniq
The Food and Drug Administration (FDA)
is investigating a possible increased risk of death due
to the cancer drug Ukoniq® (umbralisib tablets). The FDA
is re-evaluating the risk versus benefit of Ukoniq and
is continuing to look at results from the UNITY clinical
trial. Contact your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/ukoniq-umbralisib-drug-safety-communication-fda-investigating-possible-increased-risk-death-lymphoma
Source: FDA website
|
Drug Warning | 02-03-22 |
Jardiance
The Food and Drug Administration
(FDA) approved Jardiance® (empagliflozin tablets) to
treat adults with heart failure regardless of left
ventricular ejection fraction. Source: FDA website
|
Expanded Indication | 02-24-22 |
Norliqva
The Food and Drug Administration (FDA)
approved Norliqva® (amlodipine oral solution) for the
treatment of hypertension in adults and children 6 years
and older and for the treatment of coronary artery
disease and angiographically documented coronary artery
disease in individuals without heart failure or an
ejection fraction <40%. Source: FDA website
|
New Formulation | 02-24-22 |
Aspruzyo Sprinkle
The Food and Drug Administration
(FDA) approved Aspruzyo SprinkleTM (ranolazine
extended-release oral granules) for the treatment of
chronic angina. Source: FDA website
|
New Formulation | 02-28-22 |
Pyrukynd
The Food and Drug Administration (FDA)
approved Pyrukynd® (mitapivat tablets) for the treatment
of hemolytic anemia in adults with pyruvate kinase (PK)
deficiency. Source: FDA website
|
New Drug | 02-17-22 |
Carvykti
The Food and Drug Administration
(FDA) approved CarvyktiTM (ciltacabtagene autoleucel
suspension for intravenous infusion) for the treatment
of adults with relapsed or refractory multiple myeloma,
after four or more prior lines of therapy, including a
proteasome inhibitor, an immunomodulatory agent, and an
anti-CD38 monoclonal antibody. Source: FDA website
|
New Drug | 02-28-22 |
Vonjo
The Food and Drug Administration
(FDA) approved VonjoTM (pacritinib capsules) for the
treatment of adults with intermediate or high-risk
primary or secondary (post-polycythemia vera or
post-essential thrombocythemia) myelofibrosis with a
platelet count below 50 × 109/L. Source: FDA website
|
New Drug | 02-28-22 |
Opdivo
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab injection) in combination
with platinum-doublet chemotherapy for adults with
resectable non-small cell lung cancer (NSCLC) in the
neoadjuvant setting. Source: FDA website
|
Expanded Indication | 03-04-22 |
Lynparza
The Food and Drug Administration (FDA)
approved Lynparza® (olaparib tablets) for the adjuvant
treatment of adults with deleterious or suspected
deleterious germline BRCA-mutated (gBRCAm) human
epidermal growth factor receptor 2 (HER2)-negative
high-risk early breast cancer who have been treated with
neoadjuvant or adjuvant chemotherapy. Source: FDA
website
|
Expanded Indication | 03-11-22 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) as a single
agent for individuals with advanced endometrial
carcinoma that is microsatellite instability-high
(MSI-H) or mismatch repair deficient (dMMR), as
determined by a Food and Drug Administration
(FDA)-approved test, who have disease progression
following prior systemic therapy in any setting and who
are not candidates for curative surgery or radiation.
Source: FDA website
|
Expanded Indication | 03-21-22 |
Smoflipid
The Food and Drug Administration (FDA)
approved Smoflipid® (lipid injectable emulsion) as a
source of calories and essential fatty acids for
parenteral nutrition when oral or enteral nutrition is
not possible, insufficient, or contraindicated expanded
to include pediatric individuals. Source: FDA website
|
Expanded Indication | 03-22-22 |
Rinvoq
The Food and Drug Administration
(FDA) approved Rinvoq® (upadacitinib extended-release
tablets) for the treatment of adults with moderately to
severely active ulcerative colitis (UC) who have had an
inadequate response or intolerance to one or more tumor
necrosis factor (TNF) blockers. Source: FDA website
|
New Indication | 03-16-22 |
Adlarity
The Food and Drug Administration
(FDA) approved Adlarity® (donepezil transdermal system)
for the treatment of adults with mild, moderate, and
severe dementia of the Alzheimer type. Source: FDA
website
|
New Formulation | 03-11-22 |
Xelstrym
The Food and Drug Administration
(FDA) approved XelstrymTM (dextroamphetamine transdermal
system) for the treatment of
attention-deficit/hyperactivity disorder (ADHD) for
adults and pediatric individuals 6 years and older.
Source: FDA website
|
New Formulation | 03-23-22 |
Hyftor
The Food and Drug Administration (FDA)
approved HyftorTM (sirolimus topical gel) for the
treatment of facial angiofibroma associated with
tuberous sclerosis in adults and pediatric individuals 6
years of age and older. Source: FDA website
|
New Formulation | 03-22-22 |
Ztalmy
The Food and Drug Administration (FDA)
approved Ztalmy® (ganaxolone oral suspension) for the
treatment of seizures associated with cyclin-dependent
kinase-like 5 (CDKL5) deficiency disorder (CDD) in
individuals 2 years of age or older. Source: FDA website
|
New Drug | 03-18-22 |
Opdualag
The Food and Drug Administration
(FDA) approved OpdualagTM (nivolumab/relatlimab-rmbw
injection) for the treatment of adult and pediatric
individuals 12 years of age or older with unresectable
or metastatic melanoma. Source: FDA website
|
New Drug | 03-18-22 |
Pluvicto
The Food and Drug Administration (FDA)
approved PluvictoTM (lutetium Lu 177 vipivotide
tetraxetan injection) for the treatment of adults with
prostate-specific membrane antigen (PSMA)-positive
metastatic castration-resistant prostate cancer (mCRPC)
who have been treated with androgen receptor (AR)
pathway inhibition and taxane-based chemotherapy.
Source: FDA website
|
New Drug | 03-23-22 |
Sodium acetate
Fresenius Kabi announced a voluntary
recall of seven lots of sodium acetate injection due to
the presence of particulate matter.Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-recall-sodium-acetate-injection-usp-due-presence-particulate-matter
Source: FDA website
|
Drug Recall | 03-08-22 |
Quinapril/hydrochlorothiazide
Pfizer announced a voluntary recall of
six lots of AccureticTM (quinapril
HCL/hydrochlorothiazide) tablets distributed by Pfizer
as well as five lots of two authorized generics
distributed by Greenstone due to the presence of an
impurity. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuretictm-quinapril-hclhydrochlorothiazide-quinapril-and
Source: FDA website
|
Drug Recall | 03-22-22 |
Orphenadrine citrate
Sandoz announced a voluntary recall
of 13 lots of oral orphenadrine citrate 100 mg
extended-release tablets due to the presence of an
impurity. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-13-lots-orphenadrine-citrate-100-mg-extended-release-tablets-due
Source: FDA website
|
Drug Recall | 03-23-22 |
Symjepi
Adamis Pharmaceuticals announced a
voluntary recall of certain lots of SymjepiTM
(epinephrine injection) due to the potential clogging of
the needle preventing the dispensing of epinephrine.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adamis-pharmaceuticals-corporation-issues-nationwide-voluntary-recall-symjepir-epinephrine-injection
Source: FDA website
|
Drug Recall | 03-22-22 |
Fintepla
The Food and Drug Administration
(FDA) approved Fintepla® (fenfluramine oral solution)
for the treatment of seizures associated with
Lennox-Gastaut syndrome in individuals two years of age
and older. Source: FDA website
|
New Indication | 03-25-22 |
Cabenuva
The Food and Drug Administration (FDA)
approved Cabenuva (cabotegravir extended-release
injectable suspension and rilpivirine extended-release
injectable suspension) for expanded use of every 2-month
dosing regimen to include the treatment of human
immunodeficiency virus (HIV)-1 infection in adolescents
12 years of age and older and weighing at least 35 kg.
Source: FDA website
|
Expanded Indication | 03-29-22 |
Vocabria and Edurant
The Food and Drug Administration
(FDA) approved Vocabria (cabotegravir tablets) for
expanded use in combination with Edurant® (rilpivirine
tablets) as an oral, short-term treatment regimen
followed by Cabenuva injection dosing regimen for the
treatment of human immunodeficiency virus (HIV)-1 virus
infection in adolescents 12 years of age and older and
weighing at least 35 kg. Source: FDA website
|
Expanded Indication | 03-29-22 |
Tlando
The Food and Drug Administration
(FDA) approved TlandoTM (testosterone undecanoate oral
capsule) for testosterone replacement therapy in adult
males for conditions associated with a deficiency or
absence of endogenous testosterone. Source: FDA website
|
New Formulation | 03-28-22 |
Triumeq PD
The Food and Drug Administration (FDA)
approved Triumeq PD (abacavir/dolutegravir/lamivudine
dispersible tablets for oral suspension) for the
treatment of pediatric individuals weighing 10 kg to <
25 kg with human immunodeficiency virus type 1
(HIV-1). The original tablet formulation of
Triumeq was also expanded to individuals
weighing at least 10 kg. Source: FDA website
|
New Formulation | 03-30-22 |
Idarubicin
Teva Pharmaceuticals announced a
voluntary recall of one lot of idarubicin hydrochloride
injection due to the presence of particulate matter.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-idarubicin-hydrochloride-injection-usp-5-mg5-ml-due
Source: FDA website
|
Drug Recall | 03-30-22 |
North American Custom Laboratories
The Food and Drug Administration
(FDA) issued a warning not to use products intended to
be sterile produced by North American Custom
Laboratories due to a lack of sterility assurance.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-sterile-products-north-american-custom?utm_medium=email&utm_source=govdelivery
Source: FDA website
|
Drug Warning | 03-31-22 |
Iodine-containing contrast media
The Food and Drug Administration (FDA)
approved a new warning to the prescribing label for the
entire class of iodinated contrast media injections and
monitoring recommendations for children 3 years or
younger. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/iodine-containing-contrast-media-drug-safety-communication-fda-recommends-thyroid-monitoring-babies
Source: FDA website
|
Drug Warning | 03-31-22 |
Yescarta
The Food and Drug Administration
(FDA) approved Yescarta® (axicabtagene ciloleucel for
intravenous infusion) for adults with large B-cell
lymphoma (LBCL) that is refractory to first-line
chemoimmunotherapy or relapses within 12 months of
first-line chemoimmunotherapy. Source: FDA website
|
Expanded Indication | 04-01-22 |
Igalmi
The Food and Drug Administration (FDA)
approved IgalmiTM (dexmedetomidine sublingual film) for
the acute treatment of agitation associated with
schizophrenia or bipolar I or II disorder in adults.
Source: FDA website
|
New Formulation | 04-05-22 |
Vijoice
The Food and Drug Administration (FDA)
approved Vijoice® (alpelisib tablets) for the treatment
of adult and pediatric individuals 2 years of age and
older with severe manifestations of PIK3CA-related
overgrowth spectrum (PROS) who require systemic therapy.
Source: FDA website
|
New Formulation | 04-05-22 |
Xigduo XR
The Food and Drug Administration
(FDA) approved Xigduo® XR (dapagliflozin/metformin
extended-release tablet) to reduce the risk of sustained
estimated glomerular filtration rate decline, end stage
kidney disease, cardiovascular death, and
hospitalization for heart failure in adults with chronic
kidney disease at risk of progression. Source: FDA
website
|
Expanded Indication | 04-11-22 |
Xigduo XR
The Food and Drug Administration
(FDA) approved Xigduo® XR (dapagliflozin/metformin
hydrochloride extended-release tablets) for the
treatment of pediatric individuals aged 10 years and
above with type-2 diabetes (T2D). Source: FDA website
|
Expanded Indication | 6/12/2024 |
Insulin glargine
Mylan Pharmaceuticals announced a
voluntary recall of one batch of insulin glargine
injection due to the potential for a missing label.
Contact your healthcare provider for questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-nationwide-recall-one-batch-insulin
Source: FDA website
|
Drug Recall | 04-13-22 |
Zerbaxa
The Food and Drug Administration (FDA)
approved Zerbaxa® (ceftolozane sulfate/tazobactam sodium
injection) in pediatric individuals from birth to less
than 18 years of age for the treatment of complicated
urinary tract infections (cUTI), including
pyelonephritis, and complicated intra-abdominal
infections (cIAI). Source: FDA website
|
Expanded Indication | 04-21-22 |
Ultomiris
The Food and Drug Administration
(FDA) approved Ultomiris® (ravulizumab-cwvz injection)
for the treatment of adults with generalized myasthenia
gravis (gMG) who are anti-acetylcholine receptor (AChR)
antibody-positive. Source: FDA website
|
New Indication | 04-27-22 |
Epsolay
The Food and Drug Administration
(FDA) approved Epsolay® (benzoyl peroxide cream) for the
treatment of inflammatory lesions of rosacea in adults.
Source: FDA website
|
New Formulation | 04-22-22 |
Cuvrior
The Food and Drug Administration (FDA)
approved CuvriorTM (trientine tetrahydrochloride
tablets) for the treatment of adult patients with stable
Wilson’s disease who are de-coppered and tolerant to
penicillamine. Source: FDA website
|
New Formulation | 04-28-22 |
Vivjoa
The Food and Drug Administration (FDA)
approved VivjoaTM (oteseconazole capsules) to reduce the
incidence of recurrent vulvovaginal candidiasis (RVVC)
in females with a history of RVVC who are not of
reproductive potential. Source: FDA website
|
New Drug | 04-27-22 |
Camzyos
The Food and Drug Administration (FDA)
approved CamzyosTM (mavacamten capsules) for the
treatment of adults with symptomatic New York Heart
Association (NYHA) class II-III obstructive hypertrophic
cardiomyopathy (HCM) to improve functional capacity and
symptoms. Source: FDA website
|
New Drug | 04-28-22 |
Accupril
Pfizer announced a voluntary recall of
five lots of Accupril due to the presence of a
nitrosamine above the acceptable level. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuprilr-quinapril-hcl-due-n-nitroso-quinapril-content
Source: FDA website
|
Drug Recall | 04-23-22 |
Rinvoq
The Food and Drug Administration
(FDA) approved Rinvoq® (upadacitinib extended-release
tablets) for the treatment of adults with active
ankylosing spondylitis (AS) who have had an inadequate
response or intolerance to one or more tumor necrosis
factor (TNF) blockers. Source: FDA website
|
New Indication | 04-29-22 |
Olumiant
The Food and Drug Administration
(FDA) approved Olumiant® (baricitinib tablets) for the
treatment of COVID-19 in hospitalized adults requiring
supplemental oxygen, non-invasive or invasive mechanical
ventilation, or extracorporeal membrane oxygenation
(ECMO). Source: FDA approval
|
New Indication | 05-10-22 |
Qelbree
The Food and Drug Administration (FDA)
approved Qelbree® (viloxazine extended-release capsules)
for the treatment of attention deficit hyperactivity
disorder (ADHD) in adults aged 18 and older. Source: FDA
website
|
Expanded Indication | 05-02-22 |
Enhertu
The Food and Drug Administration (FDA)
approved Enhertu® (fam-trastuzumab deruxtecan-nxki
injection) for the treatment of adults with unresectable
or metastatic human epidermal growth factor receptor 2
(HER2) positive breast cancer who have received a prior
anti-HER2-based regimen either in the metastatic
setting, or in the neoadjuvant or adjuvant setting and
have developed disease recurrence during or within six
months of completing therapy. Source: FDA website
|
Expanded Indication | 05-04-22 |
Ermeza
The Food and Drug Administration (FDA)
approved ErmezaTM (levothyroxine sodium oral solution)
in adult and pediatric individuals, including neonates,
as replacement therapy in primary (thyroidal), secondary
(pituitary), and tertiary (hypothalamic) congenital or
acquired hypothyroidism. Also approved as an adjunct to
surgery and radioiodine therapy in the management of
thyrotropin-dependent well-differentiated thyroid
cancer. Source: FDA website
|
New Formulation | 04-29-22 |
Radicava ORS
The Food and Drug Administration (FDA)
approved Radicava ORS® (edaravone oral suspension) for
the treatment of adults with amyotrophic lateral
sclerosis (ALS). Source: FDA website
|
New Formulation | 05-12-22 |
Mounjaro
The Food and Drug Administration
(FDA) approved MounjaroTM (tirzepatide subcutaneous
injection) to improve blood sugar control in adults with
type 2 diabetes as an addition to diet and exercise.
Source: FDA website
|
New Drug | 05-12-22 |
Voquezna Triple Pak and Voquezna Dual Pak
The Food and Drug Administration (FDA)
approved VoqueznaTM Triple PakTM (vonoprazan
tablets/amoxicillin capsules/ clarithromycin tablets
co-packaged for oral use) and VoqueznaTM Dual PakTM
(vonoprazan tablets/amoxicillin capsules/co-packaged for
oral use) for the treatment of Helicobacter pylori (H.
pylori) infection in adults. Source: FDA website
|
New Drug | 05-03-22 |
Dupixent
The Food and Drug Administration (FDA)
approved Dupixent® (dupilumab injection)
to treat eosinophilic esophagitis (EoE) in adults and
pediatric individuals 12 years and older
weighing at least 40 kg. Source: FDA website
|
New Indication | 05-20-22 |
Vidaza
The Food and Drug Administration (FDA)
approved Vidaza® (azacitidine injection)
for pediatric individuals with newly diagnosed juvenile
myelomonocytic leukemia. Source: FDA website
|
New Indication | 05-20-22 |
Tibsovo
The Food and Drug Administration (FDA)
approved Tibsovo® (ivosidenib tablet)
in combination with azacitidine for newly diagnosed
acute myeloid leukemia (AML) with a susceptible IDH1
mutation,
as detected by an FDA-approved test in adults 75 years
or older, or who have comorbidities that preclude use of
intensive induction chemotherapy. Source: FDA website
|
Expanded Indication | 05-25-22 |
TPOXX
The Food and Drug Administration (FDA)
approved TPOXX®
(tecovirimat intravenous) for the treatment of human
smallpox disease in adults
and pediatric individuals weighing at least 3 kg.
Source: FDA website
|
New Formulation | 05-18-22 |
Tyvaso DPI
The Food and Drug Administration (FDA)
approved Tyvaso DPI™ (treprostinil oral
inhalation)
for the treatment of individuals with pulmonary arterial
hypertension (PAH) and pulmonary hypertension associated
with interstitial lung disease (PH-ILD). Source: FDA
website
|
New Formulation | 05-23-22 |
Vtama
The Food and Drug Administration (FDA)
approved Vtama®
(tapinarof topical cream) for the treatment of plaque
psoriasis in adults. Source: FDA website
|
New Drug | 05-24-22 |
Anagrelide
Teva Pharmaceuticals announced a
voluntary recall of a single lot of anagrelide
capsules due to dissolution test failure. Contact your
healthcare provider with details.
More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-anagrelide-capsules-usp-05-mg-due-dissolution-test
Source: FDA website
|
Drug Recall | 05-23-22 |
Evrysdi
The Food and Drug Administration (FDA)
approved Evrysdi® (risdiplam oral solution) to include
treatment of infants under 2 months old with spinal
muscular atrophy (SMA). Source: FDA website
|
Expanded Indication | 05-27-22 |
Opdivo
The Food and Drug Administration
(FDA) approved Opdivo® (nivolumab injection) in
combination with fluoropyrimidine- and
platinum-containing chemotherapy and Opdivo plus Yervoy
(ipilimumab injection) as a first-line treatment for
adults with unresectable advanced or metastatic
esophageal squamous cell carcinoma (ESCC) regardless of
programmed death-ligand 1 (PD-L1) status. Source: FDA
website
|
Expanded Inciation | 05-27-22 |
Kymriah
The Food and Drug Administration (FDA)
approved Kymriah® (tisagenlecleucel injection) for the
treatment of adults with relapsed or refractory
follicular lymphoma (FL) after two or more lines of
systemic therapy. Source: FDA website
|
Expanded Inciation | 05-28-22 |
Beovu
The Food and Drug Administration
(FDA) approved Beovu® (brolucizumab-dbll) for the
treatment of diabetic macular edema (DME). Source: FDA
website
|
New Indication | 05-27-22 |
Ukoniq
The Food and Drug Administration
(FDA) has withdrawn approval for the cancer medication
UkoniqTM (umbralisib tablet) due to safety concerns.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/ukoniq-umbralisib-drug-safety-communication-fda-approval-lymphoma-medicine-withdrawn-due-safety
Source: FDA website
|
Drug Warning | 06-01-22 |
CellCept
The Food and Drug Administration (FDA)
approved CellCept® (mycophenolate mofetil capsule,
tablet, oral suspension, and injection) for the
prophylaxis of organ rejection in pediatric recipients
of allogenic heart and allogenic liver transplants aged
3 months and older in combination with other
immunosuppressants. Source: FDA website
|
Expanded Indication | 06-06-22 |
Dupixent
The Food and Drug Administration
(FDA) approved Dupixent® (dupilumab injection) for the
treatment of children aged 6 months to 5 years with
moderate-to-severe atopic dermatitis whose disease is
not adequately controlled with topical prescription
therapies or for when those therapies are not advisable.
Source: FDA website
|
Expanded Indication | 06-07-22 |
Priorix
The Food and Drug Administration
(FDA) approved Priorix (measles, mumps, and rubella
vaccine, live suspension for subcutaneous injection) for
active immunization for the prevention of measles,
mumps, and rubella in individuals 12 months of age and
older. Source: FDA website
|
New Formulation | 06-03-22 |
Olumiant
The Food and Drug Administration (FDA)
approved Olumiant® (baricitinib tablets) for the
treatment of adults with severe alopecia areata. Source:
FDA website
|
New Indication | 06-13-22 |
Imcivree
The Food and Drug Administration
(FDA) approved ImcivreeTM (setmelanotide subcutaneous
injection) for chronic weight management in adult and
pediatric individuals 6 years of age and older with
obesity due to Bardet-Biedl Syndrome (BBS). Source: FDA
website
|
New Indication | 06-16-22 |
Skyrizi
The Food and Drug Administration (FDA)
approved Skyrizi® (risankizumab-rzaa injection) for the
treatment of adults with moderately to severely active
Crohn's disease. Source: FDA website
|
New Indication | 06-17-22 |
Skyrizi
The Food and Drug Administration (FDA)
approved Skyrizi® (risankizumab-rzaa injection) for the
treatment of moderately-to-severely active ulcerative
colitis in adults. Source: FDA website
|
New Indication | 6/17/2024 |
Amvuttra
The Food and Drug Administration (FDA)
approved AmvuttraTM (vutrisiran subcutaneous injection)
for the treatment of the polyneuropathy of hereditary
transthyretin-mediated amyloidosis in adults. Source:
FDA website
|
New Drug | 06-13-22 |
Zulresso
The Food and Drug Administration
(FDA) approved ZulressoTM (brexanolone injection for
intravenous use) for expansion to include individuals 15
years and older diagnosed with postpartum depression.
Source: FDA website
|
Expanded Indication | 06-16-22 |
Vaxneuvance
The Food and Drug Administration
(FDA) approved VaxneuvanceTM (pneumococcal 15-valent
conjugate vaccine intramuscular injection) expanded for
active immunization for the prevention of invasive
disease caused by certain Streptococcus pneumoniae
serotypes in individuals 6 weeks of age and older.
Source: FDA website
|
Expanded Indication | 06-22-22 |
Mekinist plus Tafinlar
The Food and Drug Administration (FDA)
approved Mekinist® (trametinib tablets) plus Tafinlar®
(dabrafenib capsules) for the treatment of adult and
pediatric individuals 6 years of age and older with
unresectable or metastatic solid tumors with BRAF V600E
mutation who have progressed following prior treatment
and have no satisfactory alternative treatment options.
Source: FDA website
|
Expanded Indication | 06-22-22 |
Breyanzi
The Food and Drug Administration (FDA)
approved Breyanzi® (lisocabtagene maraleucel suspension
for intravenous infusion) for the treatment of adults
with large B-cell lymphoma (LBCL) after one prior
therapy. Source: FDA website
|
Expanded Indication | 06-24-22 |
Qsymia
The Food and Drug Administration (FDA)
approved Qsymia® (phentermine/topiramate
extended-release capsules) for chronic weight management
in pediatric individuals aged 12 years and older who are
obese, defined as a body mass index (BMI) of 95th
percentile or greater when standardized for age and sex.
Source: FDA website
|
Expanded Indication | 06-24-22 |
Morphine sulfate
Bryant Ranch Prepack announced a
voluntary recall of one lot of morphine sulfate 30 mg
extended-release tablets and one lot of morphine sulfate
60 mg extended-release tablets due to incorrect
labeling. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bryant-ranch-prepack-inc-issues-voluntary-nationwide-recall-morphine-sulfate-30-mg-extended-release
Source: FDA website
|
Drug Recall | 06-29-22 |
Kyprolis
The Food and Drug Administration (FDA)
approved Kyprolis® (carfilzomib injection) in
combination with Sarclisa® (isatuximab-irfc injection)
and dexamethasone for the treatment of adults with
relapsed or refractory multiple myeloma (RRMM) who have
received one to three lines of therapy. Source: FDA
website
|
Expanded Indication | 06-30-22 |
Krystexxa
The Food and Drug Administration (FDA)
approved Krystexxa® (pegloticase injection) for
concomitant use with methotrexate for the treatment of
individuals with uncontrolled gout to achieve a complete
response to therapy. Source: FDA website
|
Expanded Indication | 07-07-22 |
Drospirenone
The Food and Drug Administration (FDA)
approved Drospirenone chewable tablets for use by
females of reproductive potential to prevent pregnancy.
Source: FDA website
|
New Formulation | 09-29-22 |
Venbysi XR
The Food and Drug Administration (FDA)
approved Venbysi XR (venlafaxine besylate
extended-release oral tablets) for the treatment of
major depressive disorder and generalized anxiety
disorder in adults. Source: FDA website
|
New Formulation | 09-29-22 |
Insulin glargine
Mylan Pharmaceuticals announced a
voluntary recall of one batch of insulin glargine
injection due to the potential of missing labels on some
pens. Contact your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-issues-voluntary-nationwide-recall-one-batch-insulin
Source: FDA website
|
Drug Recall | 07-06-22 |
Copiktra
The Food and Drug Administration (FDA)
is warning that results from a clinical trial show a
possible increased risk of death and serious adverse
events with the oncology medicine Copiktra® (duvelisib
capsules). The FDA will continue to evaluate the safety
of this agent. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/copiktra-duvelisib-drug-safety-communication-fda-warns-about-possible-increased-risk-death-and
Source: FDA website
|
Drug Warning | 06-30-22 |
Xalkori
The Food and Drug Administration (FDA)
approved Xalkori® (crizotinib oral pellets) 20 mg, 50
mg, and 150 mg oral pellets to for all previously
approved indications. Source: FDA website
|
New Formulation | 9/7/2023 |
Temodar
The Food and Drug Administration (FDA)
approved Temodar® (temozolomide injection) for the
adjuvant treatment of adults with newly diagnosed
anaplastic astrocytoma and the treatment of adults with
refractory anaplastic astrocytoma. Source: FDA website
|
Expanded Indication | 9/14/2023 |
Aphexda
The Food and Drug Administration (FDA)
approved AphexdaTM (motixafortide subcutaneous
injection) to mobilize hematopoietic stem cells to the
peripheral blood for collection and subsequent
autologous transplantation in people with multiple
myeloma, in combination with filgrastim
(granulocyte-colony stimulating factor [G-CSF]). Source:
FDA website
|
New Drug | 9/8/2023 |
Ojjaara
The Food and Drug Administration (FDA)
approved Ojjaara (momelotinib tablets) for the treatment
of intermediate or high-risk myelofibrosis (MF),
including primary MF or secondary MF [post-polycythemia
vera (PV) and post-essential thrombocythemia (ET)], in
adults with anemia. Source: FDA website
|
New Drug | 9/15/2023 |
Sandimmune
Novartis announced a voluntary recall
of one lot of Sandimmune® (cyclosporine oral solution)
100 mg/mL due to crystal formation observed in some
bottles. Contact your health care provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-nationwide-recall-one-lot-sandimmuner-oral-solution-cyclosporine-oral
Source: FDA website
|
Drug Recall | 9/11/2023 |
Opzelura
The Food and Drug Administration (FDA) approved
Opzelura™ (ruxolitinib cream)
for the topical treatment of nonsegmental vitiligo in
adult and pediatric individuals
12 years of age and older. Source: FDA website
|
New Indication | 07-18-22 |
Diacomit
The Food and Drug Administration (FDA)
approved Diacomit® (stiripentol capsules)
for the treatment of seizures associated with Dravet
syndrome (DS) in individuals
taking clobazam who are 6 months of age and older and
weighing 7 kg or more. Source: FDA website
|
Expanded Indication | 07-14-22 |
Zonisade
The Food and Drug Administration (FDA)
approved Zonisade™ (zonisamide oral suspension)
as adjunctive therapy for the treatment of partial onset
seizures in adults and pediatric
individuals 16 years of age and older. Source: FDA
website
|
New Formulation | 07-15-22 |
Benlysta
The Food and Drug Administration (FDA)
approved Benlysta® (belimumab injection) to include
pediatric individuals 5 to 17 years of age with active
lupus nephritis who are receiving standard therapy.
Source: FDA website
|
Expanded Indication | 07-26-22 |
Stelara
The Food and Drug Administration (FDA)
approved Stelara® (ustekinumab injection) to include the
treatment of pediatric individuals 6 years and older
with active psoriatic arthritis. Source: FDA website
|
Expanded Indication | 07-29-22 |
Rebinyn
The Food and Drug Administration (FDA)
approved Rebinyn® (coagulation factor IX, recombinant
injection) to include use in adults and children with
hemophilia B for routine prophylaxis to reduce the
frequency of bleeding episodes. Source: FDA website
|
Expanded Indication | 08-1-22 |
Tadliq
The Food and Drug Administration (FDA)
approved Tadliq® (tadalafil oral suspension) for the
treatment of pulmonary arterial hypertension (PAH) (WHO
Group 1) to improve exercise ability. Source: FDA
website
|
New Formulation | 06-17-22 |
Ultomiris
The Food and Drug Administration (FDA)
approved Ultomiris® (ravulizumab-cwvz subcutaneous
on-body injection) for the treatment of adults with
paroxysmal nocturnal hemoglobinuria (PNH) and atypical
hemolytic uremic syndrome (aHUS). Source: FDA website
|
New Formulation | 07-22-22 |
Kyzatrex
The Food and Drug Administration (FDA)
approved Kyzatrex® (testosterone undecanoate oral
capsules) for testosterone replacement therapy in adult
males for conditions associated with a deficiency or
absence of endogenous testosterone. Source: FDA website
|
New Formulation | 07-27-22 |
Zoryve
The Food and Drug Administration (FDA)
approved ZoryveTM (roflumilast topical) for topical
treatment of plaque psoriasis, including intertriginous
areas, in individuals 12 years of age and older. Source:
FDA website
|
New Formulation | 07-29-22 |
Magnesium citrate
Vi-Jon announced a voluntary recall
for all lots of all flavors of Magnesium citrate saline
laxative oral solution due to microbial contamination.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-nationwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate
Source: FDA website
|
Drug Recall | 07-28-22 |
Enhertu
The Food and Drug Administration (FDA)
approved Enhertu® (fam-trastuzumab deruxtecan-nxki
injection) for adults with unresectable or metastatic
HER2-low (IHC 1+ or IHC 2+/ISH ) breast cancer who have
received a prior chemotherapy in the metastatic setting
or developed disease recurrence during or within six
months of completing adjuvant chemotherapy. Source: FDA
website
|
Expanded Indication | 08-05-22 |
Nubeqa
The Food and Drug Administration (FDA)
approved Nubeqa® (darolutamide tablets) in combination
with docetaxel for adults with metastatic
hormone-sensitive prostate cancer (mHSPC). Source: FDA
website
|
Expanded Indication | 08-05-22 |
Xofluza
The Food and Drug Administration (FDA)
approved Xofluza® (baloxavir marboxil tablets and oral
suspension) for the treatment of acute uncomplicated
influenza in otherwise healthy children aged five to
less than 12 years of age who have been symptomatic for
no more than 48 hours. Additionally, the FDA approved
Xofluza for the prevention (post-exposure prophylaxis)
of influenza in children aged five to less than 12 years
of age following contact with someone with influenza.
Source: FDA website
|
Expanded Indication | 08-11-22 |
Enhertu
The Food and Drug Administration (FDA)
approved Enhertu® (fam-trastuzumab deruxtecan-nxki
injection) for adults with unresectable or metastatic
non-small cell lung cancer (NSCLC) whose tumors have
activating human epidermal growth factor receptor 2 HER2
(ERBB2) mutations, as detected by a Food and Drug
Administration (FDA)-approved test, and who have
received a prior systemic therapy. Source: FDA website
|
New Indication | 08-11-22 |
Myfembree
The Food and Drug Administration (FDA)
approved Myfembree® (relugolix, estradiol, and
norethindrone acetate tablets) for the treatment of
endometriosis-associated pain. Source: FDA website
|
New Indication | 08-05-22 |
Calquence
The Food and Drug Administration (FDA)
approved Calquence® (acalabrutinib tablets) for adults
with chronic lymphocytic leukemia (CLL), small
lymphocytic lymphoma (SLL) and for individuals with
relapsed or refractory mantle cell lymphoma (MCL).
Source: FDA website
|
New Formulation | 08-03-22 |
Magnesium citrate
Vi-Jon expanded a voluntary recall of
all flavors and lots within expiry of magnesium citrate
saline laxative oral solution due to microbial
contamination. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-worldwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate
Source: FDA website
|
Drug Recall | 08-04-22 |
Milk of Magnesia and Magnesium
hydroxide/aluminum hydroxide/simethicone
Plastikon Healthcare expanded a
voluntary recall of Milk of Magnesia oral suspension and
Magnesium hydroxide/aluminum hydroxide/simethicone oral
suspension due to microbial contamination. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/plastikon-healthcare-expands-voluntary-nationwide-recall-milk-magnesia-oral-suspension-and-magnesium
Source: FDA website
|
Drug Recall | 08-03-22 |
Auvelity
The Food and Drug Administration (FDA)
approved Auvelity (dextromethorphan hydrobromide and
bupropion hydrochloride
extended-release tablets) for the treatment of major
depressive disorder (MDD) in adults. Source: FDA website
|
New Formulation | 08-18-22 |
Zynteglo
The Food and Drug Administration (FDA)
approved Zynteglo® (betibeglogene autotemcel injection)
for the treatment of adult and pediatric individuals
with beta-thalassemia who require regular red blood cell
(RBC) transfusions. Source: FDA website
|
New Drug | 08-17-22 |
Takhzyro
The Food and Drug Administration (FDA)
approved Takhzyro® (lanadelumab-flyo injection) in
pediatric individuals 2 to < 12 years of age for
prophylaxis to prevent attacks of hereditary
angioedema (HAE). Source: FDA website
|
Expanded Indication | 2/3/2023 |
Synjardy and Synjardy XR
The Food and Drug Administration (FDA)
approved Synjardy® (empagliflozin/metformin tablets) and
Synjardy® XR (empagliflozin/metformin controlled-release
tablets) to include the reduction of risk for
cardiovascular death and hospitalization for heart
failure in adults with heart failure. Source: FDA
website
|
Expanded Indication | 2/6/2023 |
Cibinqo
The Food and Drug Administration (FDA)
approved Cibinqo™ (abrocitinib tablets) for pediatric
individuals 12 years of age and older with refractory,
moderate-to-severe atopic dermatitis whose disease is
not adequately controlled with other systemic drug
products, including biologics, or when use of those
therapies is inadvisable. Source: FDA website
|
Expanded Indication | 2/9/2023 |
Eylea
The Food and Drug Administration (FDA)
approved Eylea® (aflibercept intravitreal injection) for
the treatment of preterm infants with retinopathy of
prematurity (ROP). Source: FDA website
|
New Indication | 2/8/2023 |
Glatiramer acetate autoinjector devices
The Food and Drug Administration (FDA)
is alerting consumers and healthcare providers that
autoinjector
devices that are optional for use with glatiramer
acetate injection may not be compatible for use across
FDA-approved
glatiramer acetate injection drug products. Contact your
healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-caregivers-and-health-care-providers-cross-compatibility-issues-autoinjector
Source: FDA website
|
Drug Warning | 08-18-22 |
Imbruvica
The Food and Drug Administration (FDA)
approved Imbruvica® (ibrutinib tablets, capsules, and
oral suspension) for pediatric individuals ≥ 1 year of
age with chronic graft versus host disease (cGVHD) after
failure of 1 or more lines of systemic therapy. Source:
FDA website
|
New Indication | 08-24-22 |
Pemazyre
The Food and Drug Administration (FDA)
approved PemazyreTM (pemigatinib tablets) for the
treatment of adults with relapsed or refractory
myeloid/lymphoid neoplasms or MLNs with fibroblast
growth factor receptor 1 (FGFR1) rearrangement. Source:
FDA website
|
New Indication | 08-26-22 |
Imfinzi
The Food and Drug Administration (FDA)
approved Imfinzi® (durvalumab injection) in combination
with gemcitabine and cisplatin for adults with locally
advanced or metastatic biliary tract cancer (BTC).
Source: FDA website
|
New Indication | 09-02-22 |
Imfinzi
The Food and Drug Administration (FDA)
approved Imfinzi® (durvalumab injection) with
carboplatin plus paclitaxel followed by single-agent
durvalumab for adults with primary advanced or recurrent
endometrial cancer that is mismatch repair deficient
(dMMR). Source: FDA website
|
New Indication | 6/14/2024 |
Orkambi
The Food and Drug Administration (FDA)
approved Orkambi® (ivacaftor/lumacaftor tablets and oral
granules) to include the treatment of cystic fibrosis
(CF) in individuals 1 to less than 2 years of age who
are homozygous for the F508del mutation in the cystic
fibrosis transmembrane conductance regulator (CFTR)
gene. Source: FDA website
|
Expanded Indication | 09-02-22 |
Konvomep
The Food and Drug Administration (FDA)
approved KonvomepTM (omeprazole/sodium bicarbonate oral
suspension) for short-term treatment (4 to 8 weeks) of
active benign gastric ulcer and reduction of risk of
upper gastrointestinal bleeding in critically ill
adults. Source: FDA website
|
New Formulation | 08-30-22 |
Xenpozyme
The Food and Drug Administration (FDA)
approved XenpozymeTM (olipudase alfa-rpcp injection) for
the treatment of non–central nervous system (CNS)
manifestations of acid sphingomyelinase deficiency
(ASMD) in adults and pediatrics. Source: FDA website
|
New Drug | 08-31-22 |
Spevigo
The Food and Drug Administration (FDA)
approved Spevigo® (spesolimab-sbzo injection) for the
treatment of generalized pustular psoriasis flares in
adults. Source: FDA website
|
New Drug | 09-01-22 |
Daxxify
The Food and Drug Administration (FDA)
approved Daxxify® (daxibotulinumtoxinA-lanm) for the
treatment of cervical dystonia in adults. Source: FDA
website
|
New Indication | 8-10-2023 |
Akeega
The Food and Drug Administration (FDA)
approved AkeegaTM (niraparib/abiraterone acetate
tablets) for use with prednisone in adults with
deleterious or suspected deleterious BRCA-mutated
castration-resistant prostate cancer (mCRPC), as
determined by an FDA-approved test. Source: FDA website
|
New Formulation | 8-11-2023 |
Hepzato Kit
The Food and Drug Administration (FDA)
approved Hepzato Kit (melphalan for injection/hepatic
delivery system) as a liver-directed treatment for
adults with uveal melanoma with unresectable hepatic
metastases affecting less than 50% of the liver and no
extrahepatic disease, or extrahepatic disease limited to
the bone, lymph nodes, subcutaneous tissues, or lung
that is amenable to resection or radiation. Source: FDA
website
|
New Formulation | 8-14-2023 |
Zurzuvae
The Food and Drug Administration (FDA)
approved ZurzuvaeTM (zuranolone capsules) for the
treatment of postpartum depression (PPD) in adults.
Source: FDA website
|
New Drug | 8-4-2023 |
Izervay
The Food and Drug Administration (FDA)
approved IzervayTM (avacincaptad pegol intravitreal
injection) for the treatment of geographic atrophy (GA)
secondary to age-related macular degeneration (AMD).
Source: FDA website
|
New Drug | 8-4-2023 |
Talvey
The Food and Drug Administration (FDA)
approved TalveyTM (talquetamab-tgvs injection) for the
treatment of adults with relapsed or refractory multiple
myeloma who have received at least four prior lines of
therapy, including a proteasome inhibitor, an
immunomodulatory agent and an anti-CD38 monoclonal
antibody. Source: FDA website
|
New Drug | 8-9-2023 |
Elrexfio
The Food and Drug Administration (FDA)
approved ElrexfioTM (elranatamab-bcmm injection) for
adults with relapsed or refractory multiple myeloma who
have received at least four prior lines of therapy,
including a proteasome inhibitor, an immunomodulatory
agent, and an anti-CD38 monoclonal antibody. Source: FDA
website
|
New Drug | 8-14-2023 |
Sohonos
The Food and Drug Administration (FDA)
approved SohonosTM (palovarotene capsules) for the
reduction in volume of new heterotopic ossification in
adults and pediatric individuals aged 8 years and older
for females and 10 years and older for males with
fibrodysplasia ossificans progressiva (FOP). Source: FDA
website
|
New Drug | 8-16-2023 |
Terlivaz
The Food and Drug Administration (FDA)
approved Terlivaz® (terlipressin injection) to improve
kidney function in adults with hepatorenal syndrome with
rapid reduction in kidney function. Source: FDA website
|
New Drug | 09-14-22 |
Rolvedon
The Food and Drug Administration (FDA)
approved RolvedonTM (eflapegrastim-xnst injection) to
decrease the incidence of
infection, as manifested by febrile neutropenia, in
adults with non-myeloid malignancies receiving
myelosuppressive anti-cancer drugs associated with
clinically significant incidence of febrile neutropenia.
Source: FDA website
|
New Drug | 09-09-22 |
Sotyktu
The Food and Drug Administration (FDA)
approved SotyktuTM (deucravacitinib oral tablets) for
the treatment
of adults with moderate-to-severe plaque psoriasis who
are candidates for systemic therapy or phototherapy.
Source: FDA website
|
New Drug | 09-09-22 |
Retevmo
The Food and Drug Administration (FDA)
approved Retevmo® (selpercatinib capsules)
for adults with locally advanced or metastatic solid
tumors with a rearranged
during transfection (RET) gene fusion. Source: FDA
website
|
New Indication | 09-21-22 |
Aponvie
The Food and Drug Administration (FDA)
approved Aponvie™ (aprepitant injection)
for the prevention of postoperative nausea and vomiting
in adults. Source: FDA website
|
New Formulation | 09-16-22 |
Pedmark
The Food and Drug Administration (FDA)
approved Pedmark™ (sodium thiosulfate injection)
for the reduction of ototoxicity risk associated with
cisplatin in individuals 1 month of age
and older with localized, non-metastatic solid tumors.
Source: FDA website
|
New Drug | 09-20-22 |
Skysona
The Food and Drug Administration (FDA)
approved Skysona® (elivaldogene autotemcel
injection)
to slow the progression of neurologic dysfunction in
boys 4-17 years of age with early, active
cerebral adrenoleukodystrophy (CALD). Early, active CALD
refers to asymptomatic or
mildly symptomatic (neurologic function score, NFS ≤ 1)
boys who have gadolinium enhancement on brain magnetic
resonance imaging (MRI) and Loess scores of 0.5-9.
Source: FDA website
|
New Drug | 09-16-22 |
Dupixent
The Food and Drug Administration (FDA)
approved Dupixent® (dupilumab injection) for the
treatment of adults with prurigo nodularis. Source: FDA
website
|
New Indication | 09-28-22 |
Firdapse
The Food and Drug Administration (FDA)
approved Firdapse® (amifampridine tablets) to expand the
indicated age range to include pediatric individuals six
years of age and older for the treatment of
Lambert-Eaton myasthenic syndrome (LEMS).Source: FDA
website
|
Expanded Indication | 09-29-22 |
Relyvrio
The Food and Drug Administration (FDA)
approved Relyvrio (sodium phenylbutyrate and
taurursodiol for oral suspension) for the treatment of
amyotrophic lateral sclerosis (ALS) in adults. Source:
FDA website
|
New Drug | 09-29-22 |
Omlonti
The Food and Drug Administration (FDA)
approved Omlonti® (omidenepag isopropyl ophthalmic
solution) for the reduction of elevated intraocular
pressure in individuals with primary open-angle glaucoma
or ocular hypertension. Source: FDA website
|
New Drug | 09-22-22 |
Golden State Medical Supply
Golden State Medical Supply announced
a voluntary recall of one lot of clopidogrel 75 mg
tablets due to being mislabeled as atenolol 25 mg
tablets. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/golden-state-medical-supply-inc-issues-voluntary-nationwide-recall-atenolol-25-mg-tablets-and
Source: FDA website
|
Drug Recall | 09-30-22 |
Acyclovir sodium
Eugia US LLC announced a voluntary
recall of one lot of AuroMedics acyclovir sodium
injection 500 mg per 10 mL due to the presence of
particulate matter. Contact your healthcare provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eugia-us-llc-issues-voluntary-nationwide-recall-acyclovir-sodium-injection-500-mg-10-ml-50-mgml-due
Source: FDA website
|
Drug Recall | 09-27-22 |
Oxlumo
The Food and Drug Administration (FDA)
approved Oxlumo® (lumasiran injection) to include
treatment of individuals with advanced primary
hyperoxaluria type 1 (PH1). Source: FDA website
|
Expanded Indication | 06-10-22 |
Boostrix
The Food and Drug Administration (FDA)
approved Boostrix® (tetanus toxoid, reduced diphtheria
toxoid and acellular pertussis vaccine, adsorbed
injection) for immunization expansion during the third
trimester of pregnancy to prevent pertussis in infants
younger than two months of age. Source: FDA website
|
Expanded Indication | 07-10-22 |
Lyumjev
The Food and Drug Administration (FDA)
approved Lyumjev® (insulin lispro-aabc injection) to
improve glycemic control in pediatric individuals with
diabetes mellitus. Source: FDA website
|
Expanded Indication | 14-10-22 |
Furoscix
The Food and Drug Administration (FDA)
approved Furoscix® (furosemide injection for
subcutaneous use) delivered by an on-body infusor
approved for the treatment of congestion due to fluid
overload in adults with NYHA Class II/III chronic heart
failure. Source: FDA website
|
New Formulation | 07-10-22 |
Lytgobi
The Food and Drug Administration (FDA)
approved Lytgobi® (futibatinib tablets) for the
treatment of adults with previously treated
unresectable, locally advanced or metastatic
intrahepatic cholangiocarcinoma harboring FGFR2 gene
fusions or other rearrangements. Source: FDA website
|
New Drug | 30-09-22 |
Sodium bicarbonate
Exela Pharma Sciences announced a
voluntary recall of 49 lots of sodium bicarbonate 8.4%
injection due to potential safety concerns with vial
breakage and flying glass when pressurized while
preparing product for administration. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciences-llc-issues-voluntary-nationwide-recall-sodium-bicarbonate-injection-usp-84-50
Source: FDA website
|
Drug Recall | 10-14-22 |
Vemlidy
The Food and Drug Administration (FDA)
approved Vemlidy® (tenofovir alafenamide fumarate
tablets) expanded label to include treatment of chronic
hepatitis B virus infection in pediatric individuals 12
years of age and older. Source: FDA website
|
Expanded Indication | 10-17-22 |
Rinvoq
The Food and Drug Administration (FDA)
approved Rinvoq® (upadacitinib extended-release tablets)
for the treatment of adults with active non-radiographic
axial spondyloarthritis (nr-axSpA) with objective signs
of inflammation who have had an inadequate response or
intolerance to tumor necrosis factor (TNF) blocker
therapy. Source: FDA website
|
New Indication | 10-21-22 |
Tecvayli
The Food and Drug Administration (FDA)
approved TecvayliTM (teclistamab-cqyv injection for
subcutaneous use) for the treatment of adults with
relapsed or refractory multiple myeloma who have
received at least four prior lines of therapy, including
a proteasome inhibitor, an immunomodulatory agent and an
anti-CD38 monoclonal antibody. Source: FDA website
|
New Drug | 10-25-22 |
Imjudo
The Food and Drug Administration (FDA)
approved Imjudo® (tremelimumab-actl injection for
intravenous use) for treatment of adults with
unresectable hepatocellular carcinoma (uHCC) in
combination with Imfinzi® (durvalumab injection for
intravenous use). Source: FDA website
|
New Drug | 10-21-22 |
Octreotide acetate
Mylan Institutional announced a
voluntary recall of one lot of octreotide acetate 500
mcg/mL injection due to glass particulates in a syringe.
Contact your health care provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-institutional-llc-viatris-company-issues-voluntary-recall-one-lot-octreotide-acetate-injection
Source: FDA website
|
Drug Recall | 10-26-22 |
Quinapril and hydrochlorothiazide
Aurobindo Pharma announced a voluntary
recall of two lots of quinapril and hydrochlorothiazide
20 mg/12.5 mg tablets due to the detection of
N-nitroso-quinapril impurity. Contact your health care
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-recall-two-2-lots-quinapril-and
Source: FDA website
|
Drug Recall | 10-25-22 |
Cotellic
The Food and Drug Administration (FDA)
approved Cotellic® (cobimetinib tablets) for the
treatment of adults with histiocytic neoplasms. Source:
FDA website
|
New Indication | 10-28-2022 |
Dupixent
The Food and Drug Administration (FDA)
expanded approval of Dupixent® (dupilumab single-use
prefilled pen injection) to include use in pediatric
individuals 2 years of age and older for approved
indications. Source: FDA website
|
Expanded Indication | 10-17-2022 |
Wakix
The Food and Drug Administration (FDA)
approved Wakix® (pitolisant tablets) for the treatment
of excessive daytime sleepiness (EDS) in pediatric
individuals 6 years of age and older with narcolepsy.
Source: FDA website
|
Expanded Indication | 6/21/2024 |
Libtayo
The Food and Drug Administration (FDA)
approved Libtayo® (cemiplimab-rwlc injection) in
combination with platinum-based chemotherapy for adults
with advanced non-small cell lung cancer (NSCLC) with no
epidermal growth factor receptor (EGFR), anaplastic
lymphoma kinase (ALK), or ROS1 aberrations. Source: FDA
website
|
Expanded Indication | 11-08-2022 |
Adcetris
The Food and Drug Administration (FDA)
approved Adcetris® (brentuximab vedotin injection) in
combination with doxorubicin, vincristine, etoposide,
prednisone, and cyclophosphamide for pediatric
individuals 2 years of age and older with previously
untreated high risk classical Hodgkin lymphoma (cHL).
Source: FDA website
|
Expanded Indication | 11-10-2022 |
Liletta
The Food and Drug Administration (FDA)
approved Liletta® (levonorgestrel intrauterine system)
for the prevention of pregnancy for up to 8 years.
Source: FDA website
|
Expanded Indication | 11-10-2022 |
Rotarix
The Food and Drug Administration (FDA)
approved Rotarix® (rotavirus vaccine oral) as a liquid
formulation that does not require reconstitution for the
prevention of gastroenteritis caused by G1 and non-G1
types (G3, G4, and G9) in infants. Source: FDA website
|
New Formulation | 11-09-2022 |
Imjudo
The Food and Drug Administration (FDA)
approved Imjudo® (tremelimumab-actl injection) for the
treatment of adults with unresectable hepatocellular
carcinoma (uHCC) in combination with Imfinzi®
(durvalumab injection). Source: FDA website
|
New Drug | 11-10-2022 |
Elahere
The Food and Drug Administration (FDA)
approved ElahereTM (mirvetuximab soravtansine-gynx
injection) for the treatment of adults with folate
receptor alpha (FRα) positive, platinum-resistant
epithelial ovarian, fallopian tube, or primary
peritoneal cancer, who have received one to three prior
systemic treatment regimens. Source: FDA website
|
New Drug | 11-14-2022 |
Tzield
The Food and Drug Administration (FDA)
approved TzieldTM (teplizumab-mzwv injection) for the
treatment of adults with relapsed or refractory multiple
myeloma who have received at least four prior lines of
therapy, including a proteasome inhibitor,
immunomodulatory agent and an anti-CD38 monoclonal
antibody. Source: FDA website
|
New Drug | 11-17-2022 |
Trulicity
The Food and Drug Administration (FDA)
approved
Trulicity® (dulaglutide injection) as an adjunct to diet
and exercise to
improve glycemic control in pediatric individuals 10
years of age and older with type 2 diabetes
mellitus.Source: FDA website
|
Expanded Indication | 11-17-2022 |
Blincyto
The Food and Drug Administration (FDA)
approved Blincyto® (blinatumomab injection) for adult
and pediatric individuals one month and older with
CD19-positive Philadelphia chromosome-negative B-cell
precursor acute lymphoblastic leukemia (Ph-negative BCP
ALL) in the consolidation phase of multiphase
chemotherapy. Source: FDA website
|
Expanded Indication | 6/14/2024 |
Brexafemme
The Food and Drug Administration (FDA)
approved Brexafemme®
(ibrexafungerp tablets) for the reduction in incidence
of recurrent vulvovaginal candidiasis.
Source: FDA website
|
New Indication | 11-30-2022 |
Tecentriq
The Food and Drug Administration (FDA)
approved Tecentriq® (atezolizumab injection) for the
treatment of adult and pediatric individuals two years
of age
and older with unresectable or metastatic alveolar soft
part sarcoma (ASPS). Source: FDA website
|
New Indication | 12-09-2022 |
Sezaby
The Food and Drug Administration (FDA)
approved SezabyTM
(phenobarbital injection) for the treatment of neonatal
seizures. Source: FDA website
|
New Formulation | 11-17-2022 |
Jylamvo
The Food and Drug Administration (FDA)
approved Jylamvo®
(methotrexate oral solution) for the treatment of adults
with acute lymphoblastic leukemia (ALL) as part of a
combination chemotherapy maintenance regimen, treatment
of adults with mycosis fungoides, treatment of adults
with relapsed or refractory non-Hodgkin lymphoma as part
of a metronomic combination regimen, treatment of adults
with rheumatoid arthritis,
and treatment of adults with severe psoriasis. Source:
FDA website
|
New Formulation | 11-29-2022 |
Iyuzeh
The Food and Drug Administration (FDA)
approved IyuzehTM
(latanoprost ophthalmic solution) for the reduction of
elevated intraocular pressure
(IOP) in individuals with open-angle glaucoma or ocular
hypertension. Source: FDA website
|
New Formulation | 12-13-2022 |
Rezlidhia
The Food and Drug Administration (FDA)
approved Rezlidhia®
(olutasidenib capsules) for adults with relapsed or
refractory acute myeloid leukemia (AML)
with a susceptible IDH1 mutation as detected by an
FDA-approved test. Source: FDA website
|
New Drug | 12-01-2022 |
Krazati
The Food and Drug Administration (FDA)
approved KrazatiTM (adagrasib tablets)
for adults with KRAS G12C-mutated locally advanced or
metastatic non-small cell lung cancer (NSCLC),
as determined by an FDA-approved test,
who have received at least one prior systemic therapy.
Source: FDA website
|
New Drug | 12-12-2022 |
Krazati
The Food and Drug Administration (FDA)
approved Krazati® (adagrasib tablets) plus cetuximab for
adults with KRAS G12C-mutated locally advanced or
metastatic colorectal cancer (CRC), as determined by an
FDA-approved test, who have received prior treatment
with fluoropyrimidine-, oxaliplatin-, and
irinotecan-based chemotherapy. Source: FDA website
|
New Indication | 6/21/2024 |
Hemgenix
The Food and Drug Administration (FDA)
approved Hemgenix®
(etranacogene dezaparvovec-drlb injection) for the
treatment of adults with hemophilia B (congenital Factor
IX deficiency)
who currently use Factor IX prophylaxis therapy, or who
have current or historical life-threatening hemorrhage,
or have repeated, serious spontaneous bleeding episodes.
Source:
|
New Drug | 11-22-2022 |
Sodium bicarbonate
Exela Pharma Sciences announced an
expanded recall, adding 14 lots to the ongoing
voluntary recall of sodium bicarbonate injection.
Contact your health care provider with questions. More
details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciences-llc-expands-voluntary-nationwide-recall-sodium-bicarbonate-injection-usp-84-50
Source: FDA website
|
Drug Recall | 11-29-2022 |
Prolia
The Food and Drug Administration (FDA)
is investigating the risk of severe
hypocalcemia in individuals with advanced kidney disease
on dialysis treated with Prolia® (denosumab injection)
for osteoporosis.
Contact your health care provider with questions. More
details may be viewed
at:
https://www.fda.gov/safety/medical-product-safety-information/prolia-denosumab-amgen-drug-safety-communication-fda-investigating-risk-severe-hypocalcemia-patients
Source: FDA website
|
Drug Warning | 11-22-2022 |
Avycaz
The Food and Drug Administration (FDA)
approved Avycaz® (avibactam/ceftazidime injection) for
the treatment of hospital-acquired bacterial pneumonia
and ventilator-associated bacterial pneumonia
(HABP/VABP) to include pediatric individuals aged 3
months to less than 18 years. Source: FDA website
|
Expanded Indication | 12-20-22 |
Wegovy
The Food and Drug Administration (FDA)
approved Wegovy® (semaglutide injection) as an adjunct
to a reduced calorie diet and increased physical
activity for chronic weight management in pediatric
individuals aged 12 years and older with an initial body
mass index (BMI) at the 95th percentile or greater
standardized for age and sex (obesity). Source: FDA
website
|
Expanded Indication | 12-23-22 |
Pemfexy
The Food and Drug Administration (FDA)
approved PemfexyTM (pemetrexed injection) in combination
with pembrolizumab and platinum chemotherapy, for the
initial treatment of individuals with metastatic
non-squamous non-small cell lung cancer, with no
epidermal growth factor receptor (EGFR) or anaplastic
lymphoma kinase (ALK) genomic tumor aberrations. Source:
FDA website
|
Expanded Indication | 12-14-22 |
Tymlos
The Food and Drug Administration (FDA)
approved Tymlos® (abaloparatide injection) as a
treatment to increase bone density in men with
osteoporosis at high risk of fracture (defined as a
history of osteoporotic fracture or multiple risk
factors for fracture), or individuals who have failed or
are intolerant to other available osteoporosis therapy.
Source: FDA website
|
Expanded Indication | 12-20-22 |
Vraylar
The Food and Drug Administration (FDA)
approved Vraylar® (cariprazine capsules) as adjunctive
therapy to antidepressants for the treatment of major
depressive disorder (MDD) in adults. Source: FDA website
|
New Indication | 12-16-22 |
Actemra
The Food and Drug Administration (FDA)
approved Actemra® (tocilizumab injection) for the
treatment of hospitalized adults with COVID-19 who are
receiving systemic corticosteroids and require
supplemental oxygen, non-invasive or invasive mechanical
ventilation, or extracorporeal membrane oxygenation
(ECMO). Source: FDA website
|
New Indication | 12-21-22 |
Olpruva
The Food and Drug Administration (FDA)
approved OlpruvaTM (sodium phenylbutyrate for oral
suspension) for the
chronic management of adult and pediatric individuals
weighing 20 kg or greater and with a body surface area
(BSA) of 1.2 m2 or greater, with urea cycle disorders
(UCDs) involving deficiencies of carbamylphosphate
synthetase (CPS), ornithine transcarbamylase (OTC), or
argininosuccinic acid synthetase (AS). Source: FDA
website
|
New Formulation | 12-22-22 |
Sunlenca
The Food and Drug Administration (FDA)
approved Sunlenca® (lenacapavir injection and tablets)
for treatment of human immunodeficiency virus type 1
(HIV-1) infection, in combination with other
antiretroviral(s), in heavily treatment-experienced
adults with multidrug resistant (MDR) HIV-1 infection
failing their current antiretroviral regimen due to
resistance, intolerance, or safety considerations.
Source: FDA website
|
New Drug | 12-22-22 |
Briumvi
The Food and Drug Administration (FDA)
approved BriumviTM (ublituximab-xiiy injection) for the
treatment of relapsing forms of multiple sclerosis (MS),
to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary
progressive
disease, in adults. Source: FDA website
|
New Drug | 12-28-22 |
Nexobrid
The Food and Drug Administration (FDA)
approved Nexobrid® (anacaulase-bcdb topical gel) for
eschar removal
in adults with deep partial thickness and/or full
thickness thermal burns. Source: FDA website
|
New Drug | 12-28-22 |
Adstiladrin
The Food and Drug Administration (FDA)
approved Adstiladrin® (nadofaragene firadenovec-vncg for
intravesical use) for the treatment of adults with
high-risk Bacillus CalmetteGuérin (BCG)-unresponsive
non-muscle invasive bladder cancer (NMIBC) with
carcinoma in situ (CIS) with or without papillary
tumors. Source: FDA website
|
New Drug | 12-16-22 |
Lunsumio
The Food and Drug Administration (FDA)
approved LunsumioTM (mosunetuzumab-axgb) for the
treatment of adults with relapsed or refractory
follicular lymphoma after two or more lines of systemic
therapy. Source: FDA website
|
New Drug | 12-22-22 |
Vancomycin hydrochloride
Hospira announced a voluntary recall
of one lot of vancomycin hydrochloride injection.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-vancomycin-hydrochloride-injection-usp
Source: FDA website
|
Drug Recall | 12-27-22 |
Daptomycin
Accord Healthcare announced a recall
of one lot of daptomycin injection. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/accord-healthcare-inc-issues-nationwide-voluntary-recall-daptomycin-injection-500-mgvial-and
Source: FDA website
|
Drug Recall | 12-27-22 |
Quinapril
Lupin Pharmaceuticals announced a
voluntary recall of four lots of quinapril tablets due
to potential presence of an impurity. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-four-lots-quinapril-tablets-due
Source: FDA website
|
Drug Recall | 12-21-22 |
Rybelsus
The Food and Drug Administration (FDA)
approved Rybelsus® (semaglutide tablets) as a first-line
treatment option for adults with type 2 diabetes.
Source: FDA website
|
Expanded Indication | 01-12-2023 |
Adacel
The Food and Drug Administration (FDA)
approved Adacel® (tetanus toxoid, reduced diphtheria
toxoid and acellular pertussis vaccine, adsorbed [Tdap]
injection) for immunization during the third trimester
of pregnancy to prevent pertussis in infants younger
than 2 months of age. Source: FDA website
|
Expanded Indication | 01-11-2023 |
Airsupra
The Food and Drug Administration (FDA)
approved AirsupraTM (albuterol/budesonide oral
inhalation) for the as-needed treatment or prevention of
bronchoconstriction and to reduce the risk of
exacerbations in people with asthma 18 years of age and
older. Source: FDA website
|
New Formulation | 01-10-2023 |
Leqembi
The Food and Drug Administration (FDA)
approved LeqembiTM (lecanemab injection) for the
treatment of Alzheimer’s disease in people with mild
cognitive impairment or mild dementia, the population in
which treatment was initiated in clinical trials. There
are no safety or effectiveness data on initiating
treatment at earlier or later stages of the disease than
were studied. Source: FDA website
|
New Drug | 01-06-2023 |
Brukinsa
The Food and Drug Administration (FDA)
approved Brukinsa® (zanubrutinib capsules) for chronic
lymphocytic leukemia (CLL) or small lymphocytic lymphoma
(SLL). Source: FDA website
|
New Indication | 1/19/2023 |
Tukysa
The Food and Drug Administration (FDA)
approved Tukysa® (tucatinib tablets) in combination with
trastuzumab for RAS wild-type human epidermal growth
factor receptor 2 (HER2)-positive unresectable or
metastatic colorectal cancer that has progressed
following fluoropyrimidine-, oxaliplatin-, and
irinotecan-based chemotherapy. Source: FDA website
|
New Indication | 1/19/2023 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) for
adjuvant treatment following resection and
platinum-based chemotherapy for stage IB (T2a ≥4 cm),
II, or IIIA non-small cell lung cancer (NSCLC). Source:
FDA website
|
Expanded Indication | 1/26/2023 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) with
carboplatin and paclitaxel, followed by single-agent
pembrolizumab, for adults with primary advanced or
recurrent endometrial carcinoma. Source: FDA website
|
Expanded Indication | 6/17/2024 |
Odactra
The Food and Drug Administration (FDA)
approved OdactraTM (house dust mite allergen extract
tablets for sublingual use) to include treatment of
house dust mite (HDM)-induced allergic rhinitis in
individuals 12 to 17 years of age. Source: FDA website
|
Expanded Indication | 1/20/2023 |
Enjaymo
The Food and Drug Administration (FDA)
approved Enjaymo® (sutimlimab-jome injection) for the
treatment of hemolysis in adults with cold agglutinin
disease (CAD) to include individuals with or without a
history of transfusions. Source: FDA website
|
Expanded Indication | 1/25/2023 |
Rykindo
The Food and Drug Administration (FDA)
approved Rykindo® (risperidone extended-release
injectable suspension, for intramuscular use) for the
treatment of schizophrenia in adults and as monotherapy
or as adjunctive therapy to lithium or valproate for the
maintenance treatment of bipolar I disorder in adults.
Source: FDA website
|
New Formulation | 1/13/2023 |
Orserdu
The Food and Drug Administration (FDA)
approved OrserduTM (elacestrant tablets) for
postmenopausal women or adult men with estrogen receptor
(ER)-positive, human epidermal growth factor receptor 2
(HER2)-negative, ESR1-mutated advanced or metastatic
breast cancer with disease progression following at
least one line of endocrine therapy. Source: FDA website
|
New Drug | 1/27/2023 |
Jaypirca
The Food and Drug Administration (FDA)
approved JaypircaTM (pirtobrutinib tablets) for relapsed
or refractory mantle cell lymphoma (MCL) after at least
two lines of systemic therapy, including a bruton
tyrosine kinase (BTK) inhibitor. Source: FDA website
|
New Drug | 1/27/2023 |
Brenzavvy
The Food and Drug Administration (FDA)
approved Brenzavvy® (bexagliflozin tablets) as an
adjunct to diet and exercise to improve glycemic control
in adults with type 2 diabetes mellitus (T2DM). Source:
FDA website
|
New Drug | 1/20/2023 |
Revatio
The Food and Drug Administration (FDA)
approved RevatioTM (sildenafil citrate tablets) for the
treatment of pulmonary arterial hypertension (PAH) (WHO
Group I) in pediatric individuals (1 to 17 years old) to
improve exercise ability and, in pediatric individuals
too young to perform standard exercise testing,
pulmonary hemodynamics thought to underly improvements
in exercise. Source: FDA website
|
Expanded Indication | 1/31/2023 |
Trodelvy
The Food and Drug Administration (FDA)
approved Trodelvy® (sacituzumab govitecan-hziy) for
unresectable locally advanced or metastatic hormone
receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC
2+/ISH-) breast cancer in individuals who have received
endocrine-based therapy and at least two additional
systemic therapies in the metastatic setting. Source:
FDA website
|
Expanded Indication | 2/3/2023 |
Tezspire
The Food and Drug Administration (FDA)
approved TezspireTM (tezepelumab-ekko prefilled
single-use pen, self-administration) for the add-on
maintenance treatment of individuals 12 years of age and
older with severe asthma. Source: FDA website
|
New Formulation | 2/1/2023 |
Atorvaliq
The Food and Drug Administration (FDA)
approved Atorvaliq® (atorvastatin calcium oral
suspension):
--To reduce the risk of myocardial infarction (MI),
stroke, revascularization procedures, and angina in
adults with multiple risk factors for coronary heart
disease (CHD) but without clinically evident CHD, MI and
stroke in adults with type 2 diabetes mellitus with
multiple risk factors for CHD but without clinically
evident CHD, non-fatal MI, fatal and non-fatal stroke,
revascularization procedures, hospitalization for
congestive heart failure, and angina in adults with
clinically evident CHD
-- As an adjunct to diet to reduce low-density
lipoprotein cholesterol (LDL-C) in adults with primary
hyperlipidemia, adults and pediatric individuals aged 10
years and older with heterozygous familial
hypercholesterolemia (HeFH)
-- As an adjunct to other LDL-C lowering therapies, or
alone if such treatments are unavailable, to reduce
LDL-C in adults and pediatric individuals aged 10 years
and older with homozygous familial hypercholesterolemia
(HoFH)
--As an adjunct to diet for the treatment of adults with
primary dysbetalipoproteinemia and hypertriglyceridemia.
Source: FDA website
|
New Formulation | 2/1/2023 |
Jesduvroq
The Food and Drug Administration (FDA)
approved Jesduvroq (daprodustat tablets) to treat anemia
caused by chronic kidney disease (CKD) in adults who
have been on dialysis for at least four months. Source:
FDA website
|
New Drug | 2/1/2023 |
Tirosint
IBSA Pharma announced a voluntary
recall of 27 lots of Tirosint®-Sol (levothyroxine sodium
oral solution) due to subpotency. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ibsa-pharma-inc-issues-voluntary-nationwide-recall-select-lots-tirosintr-sol-levothyroxine-sodium
Source: FDA website
|
Drug Recall | 2/1/2023 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) in
combination with Padcev® (enfortumab vedotin-ejfv) for
individuals with locally advanced or metastatic
urothelial carcinoma who are ineligible for
cisplatin-containing chemotherapy. Source: FDA website
|
New Indication | 04-03-23 |
HyQvia
The Food and Drug Administration (FDA)
expanded the approval for HyQvia (immune globulin 10%
[human]
with recombinant human hyaluronidase injection) to
include children 2 to 16 years of age with primary
immunodeficiency (PI). Source: FDA website
|
Expanded Indication | 04-11-23 |
Joenja
The Food and Drug Administration
(FDA) approved Joenja® (leniolisib tablets) for the
treatment of activated phosphoinositide 3-kinase delta
(PI3Kδ) syndrome (APDS) in adult and pediatric
individuals 12 years of age and older. Source: FDA
website
|
New Drug | 03-24-23 |
Atovaquone
Camber Pharmaceuticals announced a
voluntary recall of one lot of atovaquone oral
suspension 750 mg/5 mL due to potential Bacillus cereus
contamination. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp
Source: FDA website
|
Drug Recall | 04-03-23 |
Caldolor
The Food and Drug Administration (FDA)
approved Caldolor® (ibuprofen injection for intravenous
use) expansion to include pediatric individuals aged 3
months and older for the management of mild to moderate
pain, the management of moderate to severe pain as an
adjunct to opioid analgesics, and for the reduction of
fever. Source: FDA website
|
Expanded Indication | 5/11/2023 |
Breo Ellipta
The Food and Drug Administration (FDA)
approved Breo Ellipta (fluticasone furoate/vilanterol
for oral inhalation) expansion to include maintenance
treatment of asthma for individuals aged 12 to 17 years
and new dosage strength of 50/25 mcg approved for
maintenance treatment of asthma in individuals 5 to 11
years. Source: FDA website
|
Expanded Indication | 5/12/2023 |
Lexapro
The Food and Drug Administration (FDA)
approved Lexapro® (escitalopram oxalate tablets and oral
solution) expansion to include individuals 7 to 17 years
of age for the treatment of generalized anxiety disorder
(GAD). Source: FDA website
|
Expanded Indication | 5/12/2023 |
Ayvakit
The Food and Drug Administration (FDA)
approved Ayvakit® (avapritinib tablets) for the
treatment of adults with indolent systemic mastocytosis
(ISM). Source: FDA website
|
Expanded Indication | 5/22/2023 |
Rinvoq
The Food and Drug Administration (FDA)
approved Rinvoq® (upadacitinib extended-release tablets)
for adults with moderately to severely active Crohn’s
disease who have had an inadequate response or
intolerance to one or more tumor necrosis factor (TNF)
blockers. Source: FDA website
|
New Indication | 5/18/2023 |
Brixadi
The Food and Drug Administration (FDA)
approved BrixadiTM (buprenorphine extended-release
injection for subcutaneous use) to treat moderate to
severe opioid use disorder (OUD). Source: FDA website
|
New Formulation | 5/23/2023 |
Opvee
The Food and Drug Administration (FDA)
approved Opvee® (nalmefene nasal spray) for the
emergency treatment of known or suspected opioid
overdose in adults and pediatric individuals 12 years of
age and older. Source: FDA website
|
New Formulation | 5/23/2023 |
Xacduro
The Food and Drug Administration (FDA)
approved Xacduro® (sulbactam injection; durlobactam
injection, co-packaged for intravenous use) for the
treatment of hospital-acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia caused by
susceptible strains of Acinetobacter. Source: FDA
website
|
New Drug | 5/23/2023 |
Veozah
The Food and Drug Administration (FDA)
approved VeozahTM (fezolinetant tablets) for the
treatment of moderate to severe vasomotor symptoms due
to menopause. Source: FDA website
|
New Drug | 5/12/2023 |
Miebo
The Food and Drug Administration (FDA)
approved MieboTM (perfluorohexyloctane ophthalmic
solution) for the treatment of the signs and symptoms of
dry eye disease. Source: FDA website
|
New Drug | 5/18/2023 |
Epkinly
The Food and Drug Administration (FDA)
approved EpkinlyTM (epcoritamab-bysp subcutaneous
injection) for relapsed or refractory diffuse large
B-cell lymphoma (DLBCL) not otherwise specified,
including DLBCL arising from indolent lymphoma, and
high-grade B-cell lymphoma after two or more lines of
systemic therapy. Source: FDA website
|
New Drug | 5/19/2023 |
Vyjuvek
The Food and Drug Administration (FDA)
approved VyjuvekTM (beremagene geperpavec-svdt
biological suspension mixed with excipient gel for
topical application) for the treatment of wounds in
individuals 6 months of age and older with dystrophic
epidermolysis bullosa with mutation(s) in the collagen
type VII alpha 1 chain (COL7A1) gene. Source: FDA
website
|
New Drug | 5/19/2023 |
Stimulants
The Food and Drug Administration (FDA)
is requiring updates to the Boxed Warning and other
information in the prescribing information for
prescription stimulants to ensure the labels are
consistent across the class. Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updating-warnings-improve-safe-use-prescription-stimulants-used-treat-adhd-and-other-conditions
Source: FDA website
|
Drug Warning | 5/11/2023 |
Linzess
The Food and Drug Administration (FDA)
approved Linzess® (linaclotide capsules) to treat
functional constipation in pediatric individuals 6 to 17
years of age. Source: FDA website
|
New Indication | 6-12-2023 |
Liletta
The Food and Drug Administration (FDA)
approved Liletta® (levonorgestrel intrauterine device)
for the treatment of heavy menstrual bleeding for up to
5 years in individuals who choose intrauterine
contraception as their method of contraception.
Source: FDA website
|
New Indication | 6-29-2023 |
Bylvay
The Food and Drug Administration (FDA)
approved BylvayTM (odevixibat capsules) for the
treatment of cholestatic pruritus in individuals 12
months of age and older with Alagille syndrome (ALGS).
Source: FDA website
|
New Indication | 6-13-2023 |
Triumeq; Triumeq PD
The Food and Drug Administration (FDA)
approved Triumeq; Triumeq PD
(abacavir/dolutegravir/lamivudine tablets and tablets
for oral suspension) for the treatment of human
immunodeficiency virus (HIV)-infection in pediatric
people aged at least
3 months and weighing at least 6 kg. Source: FDA website
|
Expanded Indication | 6-15-2023 |
Talzenna
The Food and Drug Administration (FDA)
approved Talzenna® (talazoparib capsules) in combination
with enzalutamide for homologous recombination repair
(HRR) gene-mutated metastatic castration-resistant
prostate cancer (mCRPC). Source: FDA website
|
Expanded Indication | 6-20-2023 |
Jardiance
The Food and Drug Administration (FDA)
approved Jardiance® (empagliflozin tablets) as addition
to diet and exercise to improve blood sugar control in
children 10 years and older with type 2 diabetes.
Source: FDA website
|
Expanded Indication | 6-20-2023 |
Synjardy
The Food and Drug Administration (FDA)
approved Synjardy® (empagliflozin/metformin
hydrochloride tablets) as addition to diet and exercise
to improve blood sugar control in children 10 years and
older with type 2 diabetes. Source: FDA website
|
Expanded Indication | 6-20-2023 |
Suflave
The Food and Drug Administration (FDA)
approved Suflave® (polyethylene glycol 3350/sodium
sulfate/potassium chloride/ magnesium sulfate/sodium
chloride for oral solution) for cleansing of the colon
in preparation for colonoscopy in adults. Source:
FDA website
|
New Formulation | 6-15-2023 |
Capvaxive
The Food and Drug Administration (FDA)
approved CapvaxiveTM (pneumococcal 21-valent conjugate
vaccine injection) for active immunization for the
prevention of invasive disease caused by certain
Streptococcus pneumoniae and S. pneumoniae serotypes in
individuals 18 years of age and older. Source: FDA
website
|
New Formulation | 6/17/2024 |
Yimmugo
The Food and Drug Administration (FDA)
approved Yimmugo (immune globulin intravenous, human -
dira, 10% liquid) for the treatment of individuals 2
years of age and older with primary humoral
immunodeficiency (PI). Source: FDA website
|
New Formulation | 6/17/2024 |
Vigafyde
The Food and Drug Administration (FDA)
approved VigafydeTM (vigabatrin oral solution) as
monotherapy for the treatment of pediatric individuals 1
month to 2 years of age with infantile spasms for whom
the potential benefits outweigh the potential risk of
vision loss. Source: FDA website
|
New Formulation | 6/17/2024 |
Adbry
The Food and Drug Administration (FDA)
approved Adbry® (tralokinumab-ldrm, single-dose
autoinjector) for self-administration for the treatment
of adults with moderate-to-severe atopic dermatitis.
Source: FDA website
|
New Formulation | 6/12/2024 |
Sofdra
The Food and Drug Administration (FDA)
approved SofdraTM (sofpironium topical gel) for the
treatment of primary axillary hyperhidrosis in adults
and pediatric individuals 9 years of age and older.
Source: FDA website
|
New Drug | 6/20/2024 |
PiaSky
The Food and Drug Administration (FDA)
approved PiaSky (crovalimab-akkz injection) for the
treatment of adults and pediatrics 13 years and older
with paroxysmal nocturnal hemoglobinuria (PNH) and body
weight of at least 40 kg. Source: FDA website
|
New Drug | 6/20/2024 |
Rytelo
The Food and Drug Administration (FDA)
approved Rytelo (imetelstat injection) for the treatment
of adults with low- to intermediate-1 risk
myelodysplastic syndromes (MDS) with
transfusion-dependent anemia requiring 4 or more red
blood cell (RBC) units over 8 weeks who have not
responded to or have lost response to or are ineligible
for erythropoiesis-stimulating agents (ESA). Source: FDA
website
|
New Drug | 6/17/2024 |
Iqirvo
The Food and Drug Administration (FDA)
approved Iqirvo® (elafibranor tablets) for the treatment
of adults with primary biliary cholangitis (PBC) either
in combination with ursodeoxycholic acid (UDCA; ursodiol
oral) with an inadequate response to ursodiol, or as
monotherapy in those unable to tolerate ursodiol.
Source: FDA website
|
New Drug | 6/10/2024 |
Lodoco
The Food and Drug Administration (FDA)
approved Lodoco® (colchicine 0.5 mg tablet) to reduce
the risk of myocardial infarction (MI), stroke, coronary
revascularization, and cardiovascular death in adults
with established atherosclerotic disease
or with multiple risk factors for cardiovascular
disease. Source: FDA website
|
New Formulation | 6-16-2023 |
Ngenla
The Food and Drug Administration (FDA)
approved NgenlaTM (somatrogon-ghla subcutaneous
injection) for treatment of pediatric individuals aged
three years and older who have growth failure due to
inadequate secretion of endogenous growth hormone.
Source: FDA website
|
New Formulation | 6-27-2023 |
Vyvgart Hytrulo
The Food and Drug Administration (FDA)
approved Vyvgart® Hytrulo (efgartigimod alfa and
hyaluronidase-qvfc subcutaneous injection) for use in
adults with generalized myasthenia gravis who also have
an antibody known as acetylcholine receptor (AchR).
It must still be administered by a healthcare provider.
Source: FDA website
|
New Formulation | 6-20-2023 |
Vyvgart Hytrulo
The Food and Drug Administration (FDA)
approved Vyvgart® Hytrulo (efgartigimod alfa and
hyaluronidase-qvfc injection) for the treatment of
adults with chronic inflammatory demyelinating
polyneuropathy (CIDP). Source: FDA website
|
New Indication | 6/21/2024 |
Elevidys
The Food and Drug Administration (FDA)
approved Elevidys (delandistrogene moxeparvovec-rokl
intravenous infusion) for the treatment of ambulatory
pediatric individuals aged 4 through 5 years with
Duchenne muscular dystrophy (DMD) with a confirmed
mutation in the DMD gene. Source: FDA website
|
New Drug | 6-22-2023 |
Elevidys
The Food and Drug Administration (FDA)
approved Elevidys® (delandistrogene moxeparvovec-rokl
injection) for expanded use in ambulatory and
non-ambulatory individuals 4 years of age and older with
Duchenne muscular dystrophy (DMD) with a confirmed
mutation in the DMD gene. Source: FDA website
|
Expanded Indication | 6/20/2024 |
Columvi
The Food and Drug Administration (FDA)
approved Columvi® (glofitamab-gxbm injection) for the
treatment of adults with relapsed or refractory (R/R)
diffuse large B-cell lymphoma (DLBCL) not otherwise
specified or large B-cell lymphoma (LBCL) arising
from follicular lymphoma, after two or more lines of
systemic therapy. Source: FDA website
|
New Drug | 6-16-2023 |
Rystiggo
The Food and Drug Administration (FDA)
approved Rystiggo® (rozanolixizumab-noli injection for
subcutaneous use) for the treatment of generalized
myasthenia gravis (gMG) in adults who are
anti-acetylcholine receptor (AChR) or
anti-muscle-specific
tyrosine kinase (MuSK) antibody positive. Source: FDA
website
|
New Drug | 6-26-2023 |
Litfulo
The Food and Drug Administration (FDA)
approved LitfuloTM (ritlecitinib capsules) for the
treatment of severe alopecia areata (AA) in adults and
adolescents 12 years and older. Source: FDA website
|
New Drug | 6-23-2023 |
Roctavian
The Food and Drug Administration (FDA)
approved Roctavian® (valoctocogene roxaparvovec-rvox
intraveous infusion) for the treatment of adult males
with severe hemophilia A (congenital factor VIII
deficiency with factor VIII activity
< 1 IU/dL) without pre-existing antibodies to
adeno-associated virus serotype 5 (AAV5)
detected by a Food and Drug Administration
(FDA)-approved test. Source: FDA website
|
New Drug | 6-29-2023 |
Dronabinol; ziprasidone
The Harvard Drug Group announced a
voluntary recall of a single lot of dronabinol capsules
2.5 mg and ziprasidone hydrochloride capsules, 20 mg due
to a label mix-up. Contact your healthcare provider with
questions. More details may be available
at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/harvard-drug-group-llc-issues-voluntary-nationwide-recall-dronabinol-capsules-usp-25-mg-and
Source: FDA website
|
Drug Recall | 6-13-2023 |
Nucynta
The Food and Drug Administration (FDA)
approved Nucynta® (tapentadol hydrochloride tablets) for
the management of acute pain severe enough to require an
opioid analgesic and for which alternative treatments
are inadequate in adults and pediatric people aged 6
years and older with a body weight of at least 40 kg.
Source: FDA website
|
Expanded Indication | 07-03-2023 |
Leqvio
The Food and Drug Administration (FDA)
approved Leqvio® (inclisiran subcutaneous injection) for
the treatment of adults with primary hyperlipidemia,
including heterozygous familial hypercholesterolemia
(HeFH), to reduce low-density lipoprotein cholesterol
(LDL-C), as an adjunct to diet and statin therapy.
Source: FDA website
|
Expanded Indication | 07-07-2023 |
Veklury
The Food and Drug Administration (FDA)
approved Veklury® (remdesivir injection for intravenous
use) to include treatment of COVID-19 in individuals
with severe renal impairment, including those on
dialysis. Source: FDA website
|
Expanded Indication | 07-13-2023 |
Ervebo
The Food and Drug Administration (FDA)
approved Erbevo® (Ebola Zaire vaccine injection, live)
to include people 12 months of age and older for the
prevention of disease caused by Zaire Ebola virus.
Source: FDA website
|
Expanded Indication | 07-27-2023 |
Lonsurf
The Food and Drug Administration (FDA)
approved Lonsurf® (trifluridine and tipiracil tablets)
in combination with bevacizumab for metastatic
colorectal cancer (mCRC) previously treated with
fluoropyrimidine-, oxaliplatin- and irinotecan-based
chemotherapy, an anti-vascular endothelial growth factor
(VEGF) biological therapy, and if RAS wild-type, an
anti-epidermal growth factor receptor (EGFR) therapy.
Source: FDA website
|
Expanded Indiation | 08-02-2023 |
Jemperli
The Food and Drug Administration (FDA)
approved Jemperli (dostarlimab-gxly injection) in
combination with carboplatin and paclitaxel, followed by
monotherapy, for primary advanced or recurrent
endometrial cancer (EC) that is mismatch repair
deficient (dMMR), as determined by an FDA-approved test,
or microsatellite instability-high (MSI-H). Source: FDA
website
|
New Indication | 07-31-2023 |
ReVive
The Food and Drug Administration (FDA)
approved ReViveTM (naloxone nasal spray) for opioid
overdose reversal for over-the-counter (OTC)
nonprescription use. Source: FDA website
|
New Formulation | 07-28-2023 |
Balfaxar
The Food and Drug Administration (FDA)
approved Balfaxar (prothrombin complex concentrate,
human-lans solution for intravenous use) for the urgent
reversal of acquired coagulation factor deficiency
induced by vitamin K antagonist (VKA, eg, warfarin)
therapy in adults with need for an urgent surgery or
invasive procedures. Source: FDA website
|
New Formulation | 07-24-2023 |
Beyfortus
The Food and Drug Administration (FDA)
approved BeyfortusTM (nirsevimab-alip injection) for the
prevention of respiratory syncytial virus (RSV) lower
respiratory tract disease (LRTD) in neonates and infants
born during or entering their first RSV season and
children up to 24 months of age who remain vulnerable to
severe RSV disease through their second RSV season.
Source: FDA website
|
New Drug | 07-01-2023 |
Vanflyta
The Food and Drug Administration (FDA)
approved Vanflyta® (quizartinib tablets) for the
treatment of adults with newly diagnosed acute myeloid
leukemia (AML) that is FLT3 internal tandem duplication
(ITD)-positive as detected by a Food and Drug
Administration (FDA)-approved test. Source: FDA website
|
New Drug | 07-20-2023 |
Ycanth
The Food and Drug Administration (FDA)
approved YcanthTM (cantharidin topical solution) for the
treatment of molluscum contagiosum (MC) in adult and
pediatric people 2 years of age and older. Source: FDA
website
|
New Drug | 07-21-2023 |
Xdemvy
The Food and Drug Administration (FDA)
approved XdemvyTM (lotilaner ophthalmic solution) for
the treatment of Demodex blepharitis. Source: FDA
website
|
New Drug | 07-24-2023 |
Tydemy
Lupin Pharmaceuticals announced a
voluntary recall of two lots of Tydemy
(drospirenone/ethinyl estradiol and levomefolate calcium
tablets) oral contraceptive due to out of specification
test results. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-2-lots-tydemytm-drospirenone-ethinyl
Source: FDA website
|
Drug Recall | 07-28-2023 |
Albuterol sulfate
Cipla Limited announced a voluntary
recall of six batches of albuterol sulfate inhalation
aerosol 90 mcg due to observed leakage through valve in
a single inhaler. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cipla-issues-voluntary-nationwide-recall-six-batches-albuterol-sulfate-inhalation-aerosol-90-mcg-200
Source: FDA website
|
Drug Recall | 07-10-2023 |
Ingrezza
The Food and Drug Administration (FDA)
approved Ingrezza® (valbenazine capsules) for the
treatment of chorea associated with Huntington's disease
(HD). Source: FDA website
|
New Indication | 08-18-23 |
Ilaris
The Food and Drug Administration (FDA)
approved Ilaris® (canakinumab injection) for gout flares
in adults in whom non-steroidal anti-inflammatory drugs
(NSAIDs) and colchicine are contraindicated, are not
tolerated, or do not provide an adequate response, and
in whom repeated courses of corticosteroids are not
appropriate. Source: FDA website
|
New Indication | 08-25-23 |
Abrysvo
The Food and Drug Administration (FDA)
approved AbrysvoTM (respiratory syncytial virus vaccine
injection) for active immunization of pregnant
individuals at 32 through 36 weeks
gestational age for the prevention of lower respiratory
tract disease (LRTD) and severe LRTD caused by
respiratory syncytial virus (RSV) in infants from birth
through 6 months of age. Source: FDA website
|
Expanded Indication | 08-21-23 |
Veklury
The Food and Drug Administration (FDA)
approved Veklury® (remdesivir injection) to include
COVID-19 treatment in people with mild to severe hepatic
impairment with no dose adjustments. Source: FDA website
|
Expanded Indication | 08-23-23 |
Reblozyl
The Food and Drug Administration (FDA)
approved Reblozyl® (luspatercept-aamt injection) for the
treatment of anemia without previous erythropoiesis
stimulating agent use (ESA-naïve) in adult patients with
very low- to intermediate-risk myelodysplastic syndromes
(MDS) who may require regular red blood cell (RBC)
transfusions. Source: FDA website
|
Expanded Indication | 08-28-23 |
Mekinist
The Food and Drug Administration (FDA)
approved Mekinist® (trametinib dimethyl sulfoxide
tablets) for extended age range of the tumor agnostic
indication from people aged 6 years of age and older to
people aged 1 year of age and older. Source: FDA website
|
Expanded Indication | 08-31-23 |
Tafinlar
The Food and Drug Administration (FDA)
approved Tafinlar® (dabrafenib mesylate capsules) for
extended age range of the tumor agnostic indication from
people aged 6 years of age and older to people aged 1
year of age and older. Source: FDA website
|
Expanded Indication | 08-31-23 |
Focinvez
The Food and Drug Administration (FDA)
approved Focinvez (fosaprepitant injection) in adults
and pediatric people 6 months of age and older, in
combination with other antiemetic agents, for the
prevention of acute and delayed nausea and vomiting
associated with initial and repeat courses of highly
emetogenic cancer chemotherapy (HEC) including high-dose
cisplatin and delayed nausea and vomiting associated
with initial and repeat courses of moderately emetogenic
cancer chemotherapy (MEC). Source: FDA website
|
New Formulation | 08-22-23 |
Eylea HD
The Food and Drug Administration (FDA)
approved Eylea® HD (aflibercept 8 mg higher dose for
intravitreal injection) for the treatment of wet
age-related macular degeneration (wAMD), diabetic
macular edema (DME), and diabetic retinopathy. Source:
FDA website
|
New Formulation | 08-18-23 |
Veopoz
The Food and Drug Administration (FDA)
approved VeopozTM (pozelimab-bbfg injection) for the
treatment of CD55-deficient protein-losing enteropathy
(PLE), also known as complement hyperactivation,
angiopathic thrombosis, and protein-losing enteropathy
(CHAPLE) disease in adult and pediatric people 1 year of
age and older. Source: FDA website
|
New Drug | 08-18-23 |
Inmar Supply Chain Solutions
Inmar Supply Chain Solutions announced
a voluntary recall of Food and Drug Administration (FDA)
regulated products contained in pallets stored in their
Arlington, Texas facility between May 1, 2022, and June
30, 2023. The recalled products were stored in this
facility during a time when there may have been a pest
control problem. In addition, because of recent
unusually hot weather, the products may have been
subjected to temperatures in excess of the storage
condition instructions on the product labeling. Contact
your healthcare provider with questions. More details
may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/inmar-supply-chain-solutions-llc-issues-voluntary-recall-product-stored-its-arlington-texas-facility
Source: FDA website
|
Drug Recall | 08-25-23 |
Digoxin
Marlex Pharmaceuticals announced a
voluntary recall of one lot of digoxin tablets 0.125 mg
and one lot of digoxin tablets 0.25 mg due to label
mix-up. Contact your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marlex-pharmaceuticals-inc-issues-voluntary-nationwide-recall-digoxin-tablets-usp-0125mg-and-digoxin
Source: FDA website
|
Drug Recall | 08-30-23 |
Bosulif
The Food and Drug Administration (FDA)
approved Bosulif® (bosutinib tablets and capsules) for
pediatric people 1 year of age and older with chronic
phase (CP) Ph+ chronic myelogenous leukemia (CML) that
is newly diagnosed (ND) or resistant or intolerant (R/I)
to prior therapy. Source: FDA website
|
Expanded Indication | 09-26-23 |
Zoryve
The Food and Drug Administration (FDA)
approved Zoryve® (roflumilast topical cream) for the
topical treatment of plaque psoriasis, including
intertriginous areas, to children ages 6 to 11 years.
Source: FDA website
|
Expanded Indication | 10-05-23 |
Jardiance
The Food and Drug Administration (FDA)
approved Jardiance® (empagliflozin tablets) to reduce
the risk of sustained decline in estimated glomerular
filtration rate (eGFR), end-stage kidney disease,
cardiovascular death and hospitalization in adults with
chronic kidney disease (CKD) at risk of progression.
Source: FDA website
|
New Indication | 09-21-23 |
Likmez
The Food and Drug Administration (FDA)
approved LikmezTM (metronidazole oral suspension) for
trichomoniasis in adults, amebiasis in adults and
pediatric people, and anaerobic bacterial infections in
adults. Source: FDA website
|
New Formulation | 09-22-23 |
Entyvio Pen
The Food and Drug Administration (FDA)
approved Entyvio® Pen (vedolizumab subcutaneous
injection) to treat moderately to severely active
ulcerative colitis (UC) in adults. Source: FDA website
|
New Dosage Form | 09-28-23 |
Empaveli
The Food and Drug Administration (FDA)
approved Empaveli® (pegcetacoplan on-body injector for
subcutaneous administration) for the treatment of adults
with paroxysmal nocturnal hemoglobinuria (PNH). Source:
FDA website
|
New Dosage Form | 09-28-23 |
Exxua
The Food and Drug Administration (FDA)
approved Exxua (gepirone extended-release tablets) for
treatment of major depressive disorder (MDD) in adults.
Source: FDA website
|
New Drug | 09-22-23 |
Rivfloza
The Food and Drug Administration (FDA)
approved RivflozaTM (nedosiran subcutaneous injection)
to lower urinary oxalate levels in children 9 years of
age and older and adults with primary hyperoxaluria type
1 (PH1) and relatively preserved kidney function, e.g.,
estimated glomerular filtration rate (eGFR) ≥30
mL/min/1.73 m2. Source: FDA website
|
New Drug | 09-29-23 |
Pombiliti
The Food and Drug Administration (FDA)
approved PombilitiTM (cipaglucosidase alfa-atga
injection for intravenous use) in combination with
OpfoldaTM (migalastat capsules) for the treatment of
adults with late-onset Pompe disease (lysosomal acid
alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and
who are not improving on their current enzyme
replacement therapy (ERT). Source: FDA website
|
New Drug | 09-28-23 |
Opfolda
The Food and Drug Administration (FDA)
approved OpfoldaTM (migalastat capsules) in combination
with PombilitiTM (cipaglucosidase alfa-atga injection
for intravenous use) for the treatment of adults with
late-onset Pompe disease (lysosomal acid
alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and
who are not improving on their current enzyme
replacement therapy (ERT). Source: FDA website
|
New Drug | 09-28-23 |
Brexfemme
Scynexis announced a voluntary recall
of two lots of Brexafemme® (ibrexafungerp tablets) due
to potential cross contamination with a
non-antibacterial beta-lactam drug substance. Contact
your healthcare provider with questions. More details
may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/scynexis-issues-voluntary-nationwide-recall-brexafemmer-ibrexafungerp-tablets-due-potential-cross
Source: FDA website
|
Drug Recall | 09-27-23 |
Sodium bicarbonate
and lidocaine hydrochloride
Hospira announced a voluntary recall
of 4.2% sodium bicarbonate injection and 1% and 2%
lidocaine hydrochloride injection due to the potential
for presence of glass particulate matter. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-42-sodium-bicarbonate-injection-usp-and-1-and-2
Source: FDA website
|
Drug Recall | 10-03-23 |
Sucralfate
VistaPharm announced a voluntary
recall of one lot of sucralfate oral suspension 1 g/10
mL due to Bacillus cereus contamination. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vistapharm-llc-issues-voluntary-nationwide-recall-sucralfate-oral-suspension-1g10ml-due-microbial
Source: FDA website
|
Drug Recall | 09-22-23 |
Betaxolol
KVK-Tech announced a voluntary recall
of one lot of betaxolol tablets 10 mg due to a single
oxycodone tablet 5 mg found on the packaging line during
the line clearance after the subject batch was packaged.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kvk-tech-inc-issues-voluntary-nationwide-recall-one-lot-betaxolol-tablets-usp-10-mg-batch-number
Source: FDA website
|
Drug Recall | 10-03-23 |
Veltassa
The Food and Drug Administration (FDA)
approved Veltassa® (patiromer oral suspension) to
include treatment of hyperkalemia in pediatric people 12
years of age and older. Source: FDA website
|
Expanded Indication | 10-2-2023 |
Braftovi and Mektovi
The Food and Drug Administration (FDA)
approved Braftovi® (encorafenib capsules) in combination
with Mektovi® (binimetinib tablets) for adults with
metastatic non-small cell lung cancer (NSCLC) with a
BRAF V600E mutation, as detected by an FDA-approved
test. Source: FDA website
|
Expanded Indication | 10-13-2023 |
Opdivo
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab intravenous injection) for
the adjuvant treatment of adult and pediatric people 12
years and older with completely resected stage IIB or
IIC melanoma. Source: FDA website
|
Expanded Indication | 10-13-2023 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab intravenous injection)
with platinum-containing chemotherapy as neoadjuvant
treatment, and with continuation of single-agent
Keytruda as post-surgical adjuvant treatment for
resectable (tumors ≥4 cm or node positive) non-small
cell lung cancer (NSCLC). Source: FDA website
|
Expanded Indication | 10-16-2023 |
Enbrel
The Food and Drug Administration (FDA)
approved Enbrel® (etanercep subcutaneous injection) for
the treatment of active juvenile psoriatic arthritis
(JPsA) in people 2 years of age and older. Source: FDA
website
|
Expanded Indication | 10-18-2023 |
Rozlytrek
The Food and Drug Administration (FDA)
approved Rozlytrek® (entrectinib capsules and oral
pellets) to include pediatric people older than 1 month
with solid tumors that have a neurotrophic tyrosine
receptor kinase (NTRK) gene fusion without a known
acquired resistance mutation, are metastatic or where
surgical resection is likely to result in severe
morbidity, and have progressed following treatment or
have no satisfactory standard therapy. Source: FDA
website
|
Expanded Indication | 10-20-2023 |
Voxzogo
The Food and Drug Administration (FDA)
approved Voxzogo® (vosoritide subcutaneous injection) to
increase linear growth in pediatric people of all ages
with achondroplasia with open epiphyses (growth plates).
Source: FDA website
|
Expanded Indication | 10-20-2023 |
Orencia
The Food and Drug Administration (FDA)
approved Orencia® (abatacept injection) for the
treatment of people 2 to 17 years of age with active
psoriatic arthritis (PsA). Source: FDA website
|
Expanded Indication | 10-30-2023 |
Tibsovo
The Food and Drug Administration (FDA)
approved Tibsovo® (ivosidenib tablets) for adults with
relapsed or refractory myelodysplastic syndromes (MDS)
with a susceptible isocitrate dehydrogenase-1 (IDH1)
mutation, as detected by an FDA-approved test. Source:
FDA website
|
New Indication | 10-24-2023 |
Vabysmo
The Food and Drug Administration (FDA)
approved VabysmoTM (faricimab-svoa intravitreal
injection) for the treatment of macular edema following
retinal vein occlusion (RVO). Source: FDA website
|
New Indication | 10-26-2023 |
Cosentyx
The Food and Drug Administration (FDA)
approved Cosentyx® (secukinumab injection) for the
treatment of moderate to severe hidradenitis suppurativa
(HS) in adults. Source: FDA website
|
New Indication | 10-31-2023 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab intravenous injection)
in combination with gemcitabine and cisplatin for the
treatment of locally advanced unresectable or metastatic
biliary tract cancer (BTC). Source: FDA website
|
New Indication | 10-31-2023 |
Cosentyx
The Food and Drug Administration (FDA)
approved Cosentyx® (secukinumab) intravenous infusion
formulation for the treatment of adults with psoriatic
arthritis (PsA), ankylosing spondylitis (AS) and
non-radiographic axial spondyloarthritis (nr-axSpA).
Source: FDA website
|
New Formulation | 10-6-2023 |
Xphozah
The Food and Drug Administration (FDA)
approved Xphozah® (tenapanor tablets) to reduce serum
phosphorus in adults with chronic kidney disease (CKD)
on dialysis as add-on therapy in people who have an
inadequate response to phosphate binders or who are
intolerant of any dose of phosphate binder therapy.
Source: FDA website
|
New Formulation | 10-17-2023 |
Qlosi
The Food and Drug Administration (FDA)
approved QlosiTM (pilocarpine 0.4% ophthalmic solution)
for the treatment of presbyopia in adults. Source: FDA
website
|
New Formulation | 10-17-2023 |
Combogesic IV
The Food and Drug Administration (FDA)
approved Combogesic® IV (acetaminophen/ibuprofen
intravenous injection) for the relief of mild to
moderate pain and the management of moderate to severe
pain as an adjunct to opioid analgesics. Source: FDA
website
|
New Formulation | 10-17-2023 |
Penbraya
The Food and Drug Administration (FDA)
approved PenbrayaTM (meningococcal groups A, B, C, W,
and Y intramuscular injection) for active immunization
to prevent invasive disease
caused by Neisseria meningitidis serogroups A, B, C, W,
and Y for people 10 through 25 years of age. Source: FDA
website
|
New Formulation | 10-20-2023 |
Cabtreo
The Food and Drug Administration (FDA)
approved CabtreoTM (clindamycin
phosphate/adapalene/benzoyl peroxide topical gel) for
the treatment of acne vulgaris in people 12 years of age
and older. Source: FDA website
|
New Formulation | 10-20-2023 |
Zymfentra
The Food and Drug Administration (FDA)
approved Zymfentra (infliximab-dyyb subcutaneous
injection) in adults for
maintenance treatment of moderately to severely active
ulcerative colitis following treatment with an
infliximab product administered intravenously and
moderately to severely active Crohn’s disease following
treatment with an infliximab product administered
intravenously. Source: FDA website
|
New Formulation | 10-20-2023 |
Velsipity
The Food and Drug Administration (FDA)
approved VelsipityTM (etrasimod tablets) for the
treatment of moderately to severely active ulcerative
colitis in adults. Source: FDA website
|
New Drug | 10-12-2023 |
Zilbrysq
The Food and Drug Administration (FDA)
approved Zilbrysq® (zilucoplan subutaneous injection)
for the treatment of generalized myasthenia gravis (gMG)
in adults who are anti-acetylcholine receptor (AChR)
antibody positive. Source: FDA website
|
New Drug | 10-17-2023 |
Bimzelx
The Food and Drug Administration (FDA)
approved Bimzelx® (bimekizumab-bkzx subcutaneous
injection) for the treatment of moderate to severe
plaque psoriasis in adults who are candidates for
systemic therapy or phototherapy. Source: FDA website
|
New Drug | 10-17-2023 |
Agamree
The Food and Drug Administration (FDA)
approved Agamree® (vamorolone oral suspension) for the
treatment of Duchenne muscular dystrophy (DMD) in people
2 years of age and older. Source: FDA website
|
New Drug | 10-26-2023 |
Omvoh
The Food and Drug Administration (FDA)
approved OmvohTM (mirikizumab-mrkz injection) for the
treatment of moderately to severely active ulcerative
colitis in adults. Source: FDA website
|
New Drug | 10-26-2023 |
Loqtorzi
The Food and Drug Administration (FDA)
approved LoqtorziTM (toripalimab-tpzi intravenous
injection) for use in combination with cisplatin and
gemcitabine for first-line treatment of adults with
metastatic or with recurrent locally advanced
nasopharyngeal carcinoma (NPC) and as a single agent for
the treatment of adults with recurrent unresectable or
metastatic NPC with disease progression on or after a
platinum-containing
chemotherapy. Source: FDA website
|
New Drug | 10-27-2023 |
Exela Pharma Sciences
Exela Pharma Sciences announced a
voluntary recall of sodium bicarbonate, midazolam, and
Elcys (cysteine hydrochloride) injections due to the
presence of particulate matter. Contact your healthcare
provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciences-llc-issues-voluntary-nationwide-recall-84-sodium-bicarbonate-injection-usp-50
Source: FDA website
|
Drug Recall | 10-26-2023 |
Epkinly
The Food and Drug Administration (FDA) approved EpkinlyTM (epcoritamab-bysp injection) for adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Source: FDA website
|
New Indication | 06-26-2024 |
Zoryve
The Food and Drug Administration (FDA) approved ZoryveTM (roflumilast topical cream) for the treatment of mild to moderate atopic dermatitis in adult and pediatric individuals 6 years of age and older. Source: FDA website
|
New Indication | 07-09-2024 |
Voquezna
The Food and Drug Administration (FDA) approved Voquezna® (vonoprazan tablets) for the relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults. Source: FDA website
|
New Indication | 07-17-2024 |
Velphoro
The Food and Drug Administration (FDA) approved Velphoro® (ferric oxyhydroxide chewable tables) for the control of serum phosphorus levels in adult and pediatric individuals 9 years of age and older with chronic kidney disease on dialysis. Source: FDA website
|
Expanded Indication | 07-01-2024 |
Xeomin
The Food and Drug Administration (FDA) approved Xeomin® (incobotulinumtoxinA intramuscular or intraglandular injection) for the temporary improvement of the appearance of upper facial lines in adults. Source: FDA website
|
Expanded Indication | 07-05-2024 |
Tepylute
The Food and Drug Administration (FDA) approved Tepylute (thiotepa injection) for the treatment of adenocarcinoma of the breast or ovary. Source: FDA website
|
New Formulation | 06-25-2024 |
Chewtadzy
The Food and Drug Administration (FDA) approved Chewtadzy (tadalafil chewable tablet) for the treatment of erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and ED plus BPH. Source: FDA website
|
New Formulation | 06-28-2024 |
Vabysmo
The Food and Drug Administration (FDA) approved VabysmoTM (faricimab-svoa 6.0 mg single-dose prefilled syringe for intravitreal injection) for use in the treatment of neovascular or wet age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Source: FDA website
|
New Formulation | 07-05-2024 |
Ohtuvayre
The Food and Drug Administration (FDA) approved OhtuvayreTM (ensifentrine oral inhalation using a standard jet nebulizer) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. Source: FDA website
|
New Drug | 06-26-2024 |
Kisunla
The Food and Drug Administration (FDA) approved KisunlaTM (donanemab-azbt injection) for the treatment of Alzheimer’s disease. Treatment should be initiated in individuals with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials. Source: FDA website
|
New Drug | 07-02-2024 |
Clonazepam
Endo announced a voluntary recall of one lot of clonazepam orally disintegrating tablets due to mislabeling. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-one-lot-clonazepam-orally-disintegrating-tablets-usp. Source: FDA website
|
Drug Recall | 07-18-2024 |
Potassium chloride
American Health Packaging on behalf of BluePoint Laboratories announced a voluntary recall of 21 batches of potassium chloride extended-release capsules 750 mg due to failed dissolution. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-health-packaging-behalf-bluepoint-laboratories-issues-voluntary-nationwide-recall-potassium Source: FDA website
|
Drug Recall | 06-25-2024 |
Potassium chloride
Glenmark Pharmaceuticals announced a voluntary recall of 114 batches of potassium chloride extended-release capsules 750 mg due to failed dissolution. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/glenmark-pharmaceuticals-inc-usa-issues-voluntary-nationwide-recall-potassium-chloride-extended Source: FDA website
|
Drug Recall | 06-25-2024 |
Acetaminophen
Hikma Pharmaceuticals is extending its recall of one lot of acetaminophen injection 1000 mg/100 mL due to the potential presence of a bag labeled dexmedetomidine HCl injection 400 mcg/100 mL inside the overwrap. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hikma-pharmaceuticals-usa-inc-extends-voluntary-nationwide-recall-one-lot-acetaminophen-injection Source: FDA website
|
Drug Recall | 07-23-2024 |
Brineura
The Food and Drug Administration (FDA) approved Brineura® (cerliponase alfa injection) expanson to slow the loss of ambulation in children of all ages with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency. Source: FDA website
|
Expanded Indication | 07-24-2024 |
Livmarli
The Food and Drug Administration (FDA) approved Livmarli® (maralixibat oral solution) to include treatment of cholestatic pruritus in individuals 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC). A high concentration formulation was also approved. Source: FDA website
|
Expanded Indication | 07-24-2024 |
Xembify
The Food and Drug Administration (FDA) approved Xembify® (immune globulin subcutaneous human-klhw injection) to include biweekly dosing and use in treatment-naive individuals for primary immunodeficiency. Source: FDA website
|
Expanded Indication | 07-29-2024 |
Palforzia
The Food and Drug Administration (FDA) approved Palforzia® (peanut allergen powder-dnfp) to include initiation of treatment, up-dosing and maintenance in individuals ages 1 through 3 years with a confirmed diagnosis of peanut allergy to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Source: FDA website
|
Expanded Indication | 07-26-2024 |
Darzalex Faspro
The Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj injection) in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in individuals with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). Source: FDA website
|
Expanded Indication | 07-30-2024 |
Jemperli
The Food and Drug Administration (FDA) approved Jemperli (dostarlimab-gxly injection) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adults with primary advanced or recurrent endometrial cancer (EC). Source: FDA website
|
Expanded Indication | 08-01-2024 |
Tofidence
The Food and Drug Administration (FDA) approved TofidenceTM (tocilizumab-bavi injection) for adults with giant cell arteritis (GCA) and hospitalized adults with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Source: FDA website
|
New Indication | 07-22-2024 |
Femlyv
The Food and Drug Administration (FDA) approved Femlyv (norethindrone acetate and ethinyl estradiol orally disintegrating tablets) for the prevention of pregnancy. Source: FDA website
|
New Formulation | 07-22-2024 |
Zituvimet XR
The Food and Drug Administration (FDA) approved Zituvimet XR (sitagliptin/metformin hydrochloride extended-release tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Source: FDA website
|
New Formulation | 07-18-2024 |
Erzofri
The Food and Drug Administration (FDA) approved Erzofri® (paliperidone palmitate extended-release injectable suspension for intramuscular injection) for the treatment of schizophrenia in adults. Source: FDA website
|
New Formulation | 07-26-2024 |
Tezruly
The Food and Drug Administration (FDA) approved Tezruly (terazosin oral solution) for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) and the treatment of hypertension alone or with other antihypertensive agents. Source: FDA website
|
New Formulation | 07-29-2024 |
Zunveyl
The Food and Drug Administration (FDA) approved Zunveyl® (benzgalantamine delayed release tablets) for the treatment of mild-to-moderate dementia in adults. Source: FDA website
|
New Drug | 07-26-2024 |
Leqselvi
The Food and Drug Administration (FDA) approved LeqselviTM (deuruxolitinib tablets) for the treatment of adults with severe alopecia areata. Source: FDA website
|
New Drug | 07-25-2024 |
ACAM2000
The Food and Drug Administration (FDA) approved ACAM2000® (smallpox and mpox vaccine, live suspension, for percutaneous use) to include prevention of mpox disease in individuals determined to be at high risk for mpox infection. Source: FDA website
|
New Indication | 08-30-2024 |
Tremfya
The Food and Drug Administration (FDA) approved Tremfya® (guselkumab injection) to treat moderate-to-severe active ulcerative colitis (UC) in adults. Source: FDA website
|
New Indication | 09-11-2024 |
Prevymis
The Food and Drug Administration (FDA) approved Prevymis® (letermovir tablets, injection, and oral pellets) to expand use to include pediatric hematopoietic stem cell transplant recipients 6 months of age and older and weighing at least 6 kg and pediatric kidney transplant recipients 12 years of age and older and weighing at least 40 kg. An oral pellet formulation was also approved. Source: FDA website
|
Expanded Indication | 08-30-2024 |
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab subcutaneous injection) to include add-on maintenance treatment of adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Source: FDA website
|
Expanded Indication | 09-12-2024 |
Boruzu
The Food and Drug Administration (FDA) approved BoruzuTM (bortezomib ready-to-use subcutaneous injection) for the treatment of adults with multiple myeloma and for the treatment of adults with mantle cell lymphoma. Source: FDA website
|
New Formulation | 09-05-2024 |
Tecentriq Hybreza
The Food and Drug Administration (FDA) approved Tecentriq HybrezaTM (atezolizumab and hyaluronidase-tqjs subcutaneous injection) for all the adult indications as the intravenous formulation including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS). Source: FDA website
|
New Formulation | 09-12-2024 |
Ocrevus Zunovo
The Food and Drug Administration (FDA) approved Ocrevus ZunovoTM (ocrelizumab & hyaluronidase-ocsq subcutaneous injection) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Source: FDA
|
New Formulation | 09-13-2024 |
Lazcluze
The Food and Drug Administration (FDA) approved LazcluzeTM (lazertinib tablets) in combination with Rybrevant (amivantamab-vmjw injection) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. Source: FDA website
|
New Drug | 08-19-2024 |
EbglyssTM
The Food and Drug Administration (FDA) approved Ebglyss (lebrikizumab subcutaneous injection) for the treatment of adults and children age 12 years and older who have moderate-to-severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies. Source: FDA website
|
New Drug | 09-13-2024 |
Veozah
The Food and Drug Administration (FDA) issued a warning that Veozah® (fezolinetant tablets), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. The FDA has added a warning about this risk to the existing warning about elevated liver function test values and required liver function testing in the prescribing information. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due Source: FDA website
|
Drug Warning | 09-12-2024 |