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 |
---|---|---|
Zeposia
The Food and Drug Administration (FDA)
approved Zeposia® (ozanimod capsules) for the
treatment of
moderately to severely active ulcerative colitis (UC) in
adults. Source: FDA website
|
New Indication | 05-27-21 |
Zipsor
The Food and Drug Administration (FDA)
approved Zipsor® (diclofenac potassium capsules) for
relief of mild
to moderate acute pain in pediatric individuals 12 years
of age and older. Source: FDA website
|
Expanded Indication | 05-25-21 |
Lorbrena
The Food and Drug Administration (FDA)
approved Lorbrena® (lorlatinib tablets) for first-line
treatment of individuals with anaplastic lymphoma kinase
(ALK)-positive non-small cell lung cancer (NSCLC).
Source: FDA website
|
New Indication | 03-03-21 |
Actemra
The Food and Drug Administration (FDA)
approved Actemra® (tocilizumab subcutaneous injection)
for slowing the rate of decline in pulmonary function in
adults with systemic sclerosis-associated interstitial
lung disease (SSc-ILD). Source: FDA website
|
New Indication | 03-04-21 |
Yervoy
The Food and Drug Administration (FDA)
approved Yervoy® (ipilimumab injection) in
combination with nivolumab for
the treatment of adults with unresectable or metastatic
melanoma. Source: FDA website
|
Expanded Indication | 05-25-21 |
Yescarta
The Food and Drug Administration (FDA)
approved Yescarta® (axicabtagene ciloleucel injection)
for the treatment of adults with relapsed or refractory
follicular lymphoma (FL) after two or more lines of
systemic therapy. Source: FDA website
|
New Indication | 03-05-21 |
Flucelvax Quadrivalent
The Food and Drug Administration (FDA)
approved Flucelvax® Quadrivalent (inactivated influenza
vaccine injection) for active immunization in
individuals 2 years of age and older against influenza
disease caused by influenza virus subtypes A and type B
contained in the vaccine. Source: FDA website
|
New Indication | 03-05-21 |
Azstarys
The Food and Drug Administration (FDA)
approved AzstarysTM
(serdexmethylphenidate/dexmethylphenidate capsules) for
the treatment of attention deficit hyperactivity
disorder (ADHD) in individuals age six years and older.
Source: FDA website
|
New Drug | 03-02-21 |
Fotivda
The Food and Drug Administration (FDA)
approved Fotivda® (tivozanib capsules) for the treatment
of adults with relapsed or refractory advanced renal
cell carcinoma (RCC) following two or more prior
systemic therapies. Source: FDA website
|
New Drug | 03-10-21 |
Spironolactone
Bryant Ranch Prepack announced a
voluntary recall of 4 lots of spironolactone tablets due
to mislabeling with the incorrect strength. 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-issues-voluntary-nationwide-recall-spironolactone-25-mg-and-50-mg-tablets-due
Source: FDA website
|
Drug Recall | 03-10-21 |
Camcevi
The Food and Drug Administration (FDA)
approved Camcevi® (leuprolide mesylate subcutaneous
injection depot)
for the treatment of advanced prostate cancer. Source:
FDA website
|
New Formulation | 05-25-21 |
Myfembree
The Food and Drug Administration (FDA)
approved Myfembree®
(relugolix/estradiol/norethindrone acetate tablets)
for the management of heavy menstrual bleeding
associated with uterine leiomyomas (fibroids) in
premenopausal women. Source: FDA website
|
New Drug | 05-26-21 |
Lumakras
The Food and Drug Administration (FDA)
approved LumakrasTM (sotorasib tablets) for the
treatment of 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 | 05-28-21 |
Nurtec ODT
The Food and Drug Administration (FDA)
approved Nurtec® ODT (rimegepant orally
disintegrating tablets) for
the preventive treatment of episodic migraine in adults.
Source: FDA website
|
New Indication | 05-27-21 |
Medical Action Industries
Medical Action Industries announced a
voluntary recall of Medical Convenience Kits that
include the BD/Carefusion Chloraprep 3 mL
applicator due to risk of fungal contamination. Contact
your healthcare provider with questions. More details
may
be viewed at:
https://www.fda.gov/medical-devices/medical-device-recalls/medical-action-industries-inc-306-recalls-medical-convenience-kits-risk-fungal-aspergillus
Source: FDA website
|
Drug Recall | 05-24-21 |
Ocaliva
The Food and Drug Administration (FDA)
is restricting the use of Ocaliva® (obeticholic acid
tablets) in individuals with primary biliary
cholangitis with advanced liver cirrhosis due to the
potential for serious harm. Contact your healthcare
provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/ocaliva-obeticholic-acid-intercept-pharmaceuticals-drug-safety-communication-due-risk-serious-liver
Source: FDA website
|
Drug Warning | 05-26-21 |
Xalkori
The Food and Drug Administration (FDA)
approved Xalkori® (crizotinib capsules) for pediatric
individuals 1 year of age and older and young adults
with relapsed or refractory, systemic anaplastic large
cell lymphoma (ALCL) that is anaplastic lymphoma kinase
(ALK)-positive. Source: FDA website
|
Expanded Indication | 01-14-21 |
Nostrum Laboratories
Nostrum Laboratories announced a
voluntary recall of one lot of metformin extended
release 750 mg tablets due to N-nitrosodimethylamine
(NDMA) content above the acceptable limit. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-expands-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets
Source: FDA website
|
Drug Recall | 01-05-21 |
Nostrum Laboratories
Nostrum Laboratories announced a
voluntary recall of one additional lot of extended
release metformin due to NDMA content above the
acceptable limit. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin?utm_medium=email&utm_source=govdelivery
Source: FDA website
|
Drug Recall | 01-06-21 |
Paroex
Precision Dose announced a voluntary
recall of all lots of Paroex® (chlorhexidine gluconate
oral rinse) due to potential for microbial
contamination. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/precision-dose-inc-issues-voluntary-nationwide-recall-paroex-chlorhexidine-gluconate-oral-rinse-usp
Source: FDA website
|
Drug Recall | 01-05-21 |
Curative SARS-CoV-2 Test
The Food and Drug Administration (FDA)
is alerting healthcare providers and consumers of the
risk of false results with the Curative SARS-CoV-2 test.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/medical-devices/safety-communications/risk-false-results-curative-sars-cov-2-test-covid-19-fda-safety-communication
Source: FDA website
|
Drug Warning | 01-07-21 |
Ketorolac tromethamine
Fresenius Kabi announced a voluntary
recall of a single lot of ketorolac tromethamine
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-nationwide-recall-ketorolac-tromethamine-injection-usp-due-presence
Source: FDA website
|
Drug Recall | 01-10-21 |
Enhertu
The Food and Drug Administration (FDA)
approved Enhertu® (fam-trastuzumab deruxtecan-nxki
injection) for adults with locally advanced or
metastatic human epidermal growth factor receptor 2
(HER2)-positive gastric or gastroesophageal (GEJ)
adenocarcinoma who have received a prior
trastuzumab-based regimen. Source: FDA website
|
New Indication | 01-15-21 |
Darzalex Faspro
The Food and Drug Administration (FDA)
approved Darzalex FasproTM
(daratumumab/hyaluronidase-fihj injection) for use in
combination with bortezomib, cyclophosphamide and
dexamethasone (VCd), to treat adults with newly
diagnosed light-chain (AL) amyloidosis. Source: FDA
website
|
New Indication | 01-15-21 |
Darzalex Faspro
The Food and Drug Administration (FDA)
approved Darzalex FasproTM
(daratumumab/hyaluronidase-fihj injection) for the
treatment of multiple myeloma in combination with
bortezomib, thalidomide, and dexamethasone in newly
diagnosed individuals who are eligible for autologous
stem cell transplant. Source: FDA website
|
New Indication | 01-11-21 |
Spritam
The Food and Drug Administration (FDA)
approved Spritam® (levetiracetam tablets) for the
treatment of partial-onset seizures in individuals 4
years of age and older weighing more than 20 kg. Source:
FDA website
|
Expanded Indication | 01-19-21 |
Verquvo
The Food and Drug Administration (FDA)
approved Verquvo® (vericiguat tablets) to reduce the
risk of cardiovascular death and heart failure (HF)
hospitalization following a hospitalization for heart
failure or need for outpatient IV diuretics, in adults
with symptomatic chronic HF and ejection fraction less
than 45%. Source: FDA website
|
New Drug | 01-20-21 |
Cabenuva
The Food and Drug Administration (FDA)
approved Cabenuva (cabotegravir/rilpivirine
extended-release injection) for the treatment of human
immunodeficiency virus (HIV)-1 infection in adults to
replace the current antiretroviral regimen in those who
are virologically suppressed (HIV-1 RNA less than 50
copies/mL) on a stable antiretroviral regimen with no
history of treatment failure and with no known or
suspected resistance to either cabotegravir or
rilpivirine. Source: FDA website
|
New Drug | 01-21-21 |
Vocabria
The Food and Drug Administration (FDA)
approved Vocabria (cabotegravir tablets) in combination
with rilpivirine for short-term treatment of human
immunodeficiency virus (HIV)-1 infection in adults who
are virologically suppressed (HIV-1 RNA less than 50
copies/mL) on a stable antiretroviral regimen with no
history of treatment failure and with no known or
suspected resistance to either cabotegravir or
rilpivirine, for use as: oral lead-in to assess the
tolerability of cabotegravir prior to administration of
Cabenuva (cabotegravir/rilpivirine extended-release
injection) or oral therapy for individuals who will miss
planned injection dosing with Cabenuva. Source: FDA
website
|
New Drug | 01-21-21 |
Opdivo
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab injection) in combination
with Cabometyx (cabozantinib tablets) as first-line
treatment for individuals with advanced renal cell
carcinoma. Source: FDA website
|
Expanded Indication | 01-22-21 |
Edurant
The Food and Drug Administration (FDA)
approved Edurant® (rilpivirine tablets) in combination
with cabotegravir for short-term treatment of human
immunodeficiency virus (HIV)-1 infection in adults who
are virologically suppressed (HIV-1 RNA less than 50
copies/mL) on a stable antiretroviral regimen with no
history of treatment failure and with no known or
suspected resistance to either cabotegravir or
rilpivirine, for use as: oral lead-in to assess the
tolerability of rilpivirine prior to administration of
Cabenuva (cabotegravir/rilpivirine extended-release
injection) or oral therapy for individuals who will miss
planned injection dosing with Cabenuva. Source: FDA
website
|
Expanded Indication | 01-21-21 |
Carbaglu
The Food and Drug Administration (FDA)
approved Carbaglu® (carglumic acid tablets for oral
suspension) for adjunctive treatment of acute
hyperammonemia due to propionic acidemia or
methylmalonic acidemia. Source: FDA website
|
New Indication | 01-22-21 |
Nplate
The Food and Drug Administration (FDA)
approved Nplate® (romiplostim injection) to increase
survival in adults and in pediatric individuals
(including term neonates) acutely exposed to
myelosuppressive doses of radiation. Source: FDA website
|
New Indication | 01-28-21 |
Lupkynis
The Food and Drug Administration (FDA)
approved LupkynisTM (voclosporin capsules) in
combination with a background immunosuppressive therapy
regimen for the treatment of adults with active lupus
nephritis. Source: FDA website
|
New Drug | 01-22-21 |
Nostrum Laboratories
Nostrum Laboratories announced a
voluntary recall of one additional lot of extended
release metformin due to N-nitrosodimethylamine (NDMA)
content above the acceptable limit. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-expands-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0
Source: FDA website
|
Drug Recall | 01-26-21 |
Cisatracurium besylate
Meitheal Pharmaceuticals announced a
voluntary recall of one lot of Cisatracurium besylate
injection 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/meitheal-pharmaceuticals-inc-issues-voluntary-nationwide-recall-cisatracurium-besylate-injection-usp
Source: FDA website
|
Drug Recall | 01-28-21 |
Rapivab
The Food and Drug Administration (FDA)
approved Rapivab® (peramivir injection) for the
treatment of acute uncomplicated influenza in
individuals 6 months and older who have been symptomatic
for no more than two days. Source: FDA website
|
Expanded Indication | 01-28-21 |
Gocovri
The Food and Drug Administration (FDA)
approved Gocovri® (amantadine extended-release capsules)
as an adjunctive treatment to levodopa/carbidopa in
individuals with Parkinson’s disease experiencing OFF
episodes. Source: FDA website
|
New Indication | 02-01-21 |
Posimir
The Food and Drug Administration (FDA)
approved Posimir® (bupivacaine solution for infiltration
use) in adults for administration into the subacromial
space under direct arthroscopic visualization to produce
post-surgical analgesia for up to 72 hours following
arthroscopic subacromial decompression. Source: FDA
website
|
New Formulation | 02-01-21 |
Tepmetko
The Food and Drug Administration (FDA)
approved Tepmetko® (tepotinib tablets) for the treatment
of adults with metastatic non-small cell lung cancer
(NSCLC) harboring mesenchymal-epithelial transition
(MET) exon 14 skipping alterations. Source: FDA website
|
New Drug | 02-03-21 |
Enoxaparin sodium
Apotex announced a voluntary recall of
two lots of enoxaparin sodium injection due to
mislabeling of syringe barrel measurement markings.
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-enoxaparin-sodium-injection-usp-due-mislabeling
Source: FDA website
|
Drug Recall | 02-03-21 |
Xeljanz and Xeljanz XR
The Food and Drug Administration (FDA)
is alerting consumers that preliminary results from a
safety clinical trial show an increased risk of serious
heart-related problems and cancer with the arthritis and
ulcerative colitis medicine Xeljanz® (tofacitinib
tablets) and Xeljanz® XR (tofacitinib extended-release
tablets) compared to another type of medicine called
tumor necrosis factor (TNF) inhibitors. The FDA required
the safety trial, which also investigated other
potential risks including blood clots in the lungs and
death. Those final results are not yet available.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/xeljanz-xeljanz-xr-tofacitinib-drug-safety-communication-initial-safety-trial-results-find-increased
Source: FDA website
|
Drug Warning | 02-04-21 |
Libtayo
The Food and Drug Administration (FDA)
approved Libtayo® (cemiplimab-rwlc injection) for
individuals with advanced basal cell carcinoma (BCC)
previously treated with a hedgehog pathway inhibitor
(HHI) or for whom an HHI is not appropriate. Source: FDA
website
|
New Indication | 02-09-21 |
Botox
The Food and Drug Administration (FDA)
approved Botox® (onabotulinumtoxinA injection) for the
treatment of detrusor (bladder muscle) overactivity
associated with a neurologic condition in pediatric
individuals 5 years of age and older who have an
inadequate response to or are intolerant of
anticholinergic medication. Source: FDA website
|
New Indication | 02-09-21 |
Panzyga
The Food and Drug Administration (FDA)
approved Panzyga® (immune globulin injection) for the
treatment of adults with chronic inflammatory
demyelinating polyneuropathy (CIDP). Source: FDA
|
New Indication | 02-11-21 |
Ukoniq
The Food and Drug Administration (FDA)
approved Ukoniq® (umbralisib tablets) for the treatment
of adults with relapsed or refractory marginal zone
lymphoma (MZL) who have received at least one prior
anti-CD20-based regimen and relapsed or refractory
follicular lymphoma (FL) who have received at least
three prior lines of systemic therapy. Source: FDA
website
|
New Drug | 02-05-21 |
Breyanzi
The Food and Drug Administration (FDA)
approved Breyanzi® (lisocabtagene maraleucel suspension
for intravenous infusion) for the treatment of adults
with relapsed or refractory large B-cell lymphoma after
two or more lines of systemic therapy. Source: FDA
website
|
New Drug | 02-05-21 |
Evkeeza
The Food and Drug Administration (FDA)
approved EvkeezaTM (evinacumab-dgnb injection) as an
add-on treatment for individuals aged 12 years and older
with homozygous familial hypercholesterolemia (HoFH), a
genetic condition that causes severely high cholesterol.
Source: FDA website
|
New Drug | 02-11-21 |
Cosela
The Food and Drug Administration (FDA)
approved CoselaTM (trilaciclib injection) to reduce the
frequency of chemotherapy-induced bone marrow
suppression in adults receiving certain types of
chemotherapy for extensive-stage small cell lung cancer.
Source: FDA website
|
New Drug | 02-12-21 |
Entresto
The Food and Drug Administration (FDA)
approved Entresto® (sacubitril/valsartan tablets) in
chronic heart failure to include individuals with heart
failure with reduced ejection fraction (HFrEF), as well
as many with heart failure with preserved ejection
fraction (HFpEF). Source: FDA website
|
New Indication | 02-16-21 |
Libtayo
The Food and Drug Administration (FDA)
approved Libtayo® (cemiplimab-rwlc injection) for
individuals with advanced basal cell carcinoma (BCC)
previously treated with a hedgehog pathway inhibitor
(HHI) or for whom an HHI is not appropriate. Source: FDA
website
|
New Indication | 02-22-21 |
Humira
The Food and Drug Administration (FDA)
approved Humira® (adalimumab injection) for the
treatment of moderately to severely active ulcerative
colitis in pediatric individuals 5 years of age and
older. Source: FDA website
|
New Indication | 02-24-21 |
Amondys 45
The Food and Drug Administration (FDA)
approved Amondys 45 (casimersen injection) for the
treatment of Duchenne muscular dystrophy (DMD) in
individuals who have a confirmed mutation of the DMD
gene that is amenable to exon 45 skipping. Source: FDA
website
|
New Drug | 02-25-21 |
Nulibry
The Food and Drug Administration (FDA)
approved NulibryTM (fosdenopterin injection) to reduce
the risk of mortality in individuals with molybdenum
cofactor deficiency (MoCD) Type A. Source: FDA website
|
New Drug | 02-26-21 |
Pepaxto
The Food and Drug Administration (FDA)
approved Pepaxto® (melphalan flufenamide injection) in
combination with dexamethasone, for the treatment of
adults with relapsed or refractory multiple myeloma, who
have received at least four prior lines of therapy and
whose disease is refractory to at least one proteasome
inhibitor, one immunomodulatory agent, and one
CD38-directed monoclonal antibody. Source: FDA website
|
New Drug | 02-26-21 |
Fabrazyme
The Food and Drug Administration (FDA)
approved Fabrazyme® (agalsidase beta injection) for
the treatment of adult and pediatric individuals 2 years
of age and older with Fabry disease. Source: FDA website
|
New Indication | 03-11-21 |
Arcalyst
The Food and Drug Administration (FDA)
approved Arcalyst® (rilonacept injection) for the
treatment of recurrent pericarditis and to reduce the
risk of recurrence in individuals 12 years and older.
Source: FDA website
|
New Indication | 03-18-21 |
Kimyrsa
The Food and Drug Administration (FDA)
approved Kimyrsa™ (oritavancin injection) for the
treatment of adults with acute bacterial skin and skin
structure infections (ABSSSI). Source: FDA website
|
New Drug | 03-15-21 |
Ponvory
The Food and Drug Administration (FDA)
approved Ponvory™ (ponesimod tablets) for the
treatment of adults with relapsing forms of multiple
sclerosis (MS), to include clinically isolated syndrome,
relapsing-remitting disease and active secondary
progressive disease. Source: FDA website
|
New Drug | 03-18-21 |
Phenylephrine
Sagent Pharmaceuticals announced a
voluntary recall of three lots of phenylephrine
hydrochloride injection due to potentially loose crimped
vial overseals. Contact your healthcare provider with
questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-inc-issues-voluntary-nationwide-recall-phenylephrine-hydrochloride-injection
Source: FDA website
|
Drug Recall | 03-12-21 |
Abecma
The Food and Drug Administration (FDA)
approved Abecma®
(idecabtagene vicleucel injection) for the treatment of
adults with relapsed or
refractory multiple myeloma after four or more prior
lines of therapy, including
an immunomodulatory agent, a proteasome inhibitor, and
an anti-CD38 monoclonal antibody. Source: FDA website
|
New Drug | 03-26-21 |
Acyclovir
Zydus Pharmaceuticals announced a
voluntary recall of four lots of
acyclovir sodium injection 50 mg/mL due to complaints of
crystallization in vials. Contact
your healthcare provider with questions. More details
may be viewed
at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/zydus-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-acyclovir-sodium-injection-50-mgml
Source: FDA website
|
Drug Recall | 03-25-21 |
Benzedrex
The Food and Drug Administration (FDA)
is warning that the abuse and
misuse of the over-the-counter (OTC) nasal decongestant
propylhexedrine can lead to serious
harm such as heart and mental health problems. Contact
your healthcare provider with questions.
More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/benzedrex-propylhexedrine-drug-safety-communication-fda-warns-abuse-and-misuse-nasal-decongestant
Source: FDA website
|
Drug Warning | 03-25-21 |
ChloraPrep
BD (Becton, Dickinson and Company) has
expanded a voluntary recall that
was initiated on June 23, 2020 for specified catalog
numbers of the ChloraPrep™ 3 mL applicator
due to possible fungal contamination under certain
environmental conditions. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-expands-voluntary-recall-chlorapreptm-3-ml-applicator-nationwide-include-all-us-states
Source: FDA website
|
Drug Recall | 03-22-21 |
Exparel
The Food and Drug Administration (FDA)
approved Exparel® (bupivacaine liposome injection)
to include use in individuals 6 years of age and older
for single-dose infiltration to produce postsurgical
local analgesia. Source: FDA website
|
Expanded Indication | 03-22-21 |
Guanfacine
Apotex announced a voluntary recall of
three lots of guanfacine extended-release tablets 2 mg
due to trace amounts of quetiapine fumarate in one lot.
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-guanfacine-extended-release-tablets-2mg-due-trace
Source: FDA website
|
Drug Recall | 03-31-21 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) in
combination
with platinum and fluoropyrimidine-based chemotherapy
for individuals with metastatic or locally advanced
esophageal or
gastroesophageal (GEJ) (tumors with epicenter 1 to 5
centimeters above the gastroesophageal junction)
carcinoma who
are not candidates for surgical resection or definitive
chemoradiation. Source: FDA website
|
New Indication | 03-22-21 |
Lamictal
A Food and Drug Administration (FDA)
review of a study showed a potential increased risk of
heart
rhythm problems in individuals with heart diease who are
taking Lamictal (lamotrigine). Contact your healthcare
provider
with questions. More details may be viewed at:
https://www.fda.gov/safety/medical-product-safety-information/lamictal-lamotrigine-drug-safety-communication-studies-show-increased-risk-heart-rhythm-problems
Source: FDA website
|
Drug Warning | 03-21-21 |
Myrbetriq
The Food and Drug Administration (FDA)
approved Myrbetriq® (mirabegron extended-release
tablets)
for neurogenic detrusor overactivity (NDO) in pediatric
individuals aged 3 years and older and weighing 35 kg or
more. Source: FDA website
|
Expanded Indication | 03-25-21 |
Myrbetriq
The Food and Drug Administration (FDA)
approved Myrbetriq® (mirabegron extended-release
oral suspension)
for neurogenic detrusor overactivity (NDO) in pediatric
individuals aged 3 years and older and weighing 35 kg or
more. Source: FDA website
|
New Formulation | 03-25-21 |
Praluent
The Food and Drug Administration (FDA)
approved Praluent™ (alirocumab injection) for
adults with
homozygous familial hypercholesterolemia (HoFH).
Praluent is not intended to be used alone but instead
added to other
treatments for HoFH. Source: FDA website
|
New Indication | 04-01-21 |
Qelbree
The Food and Drug Administration (FDA)
approved Qelbree™ (viloxazine extended-release
capsules)
for the treatment of attention deficit hyperactivity
disorder (ADHD) in pediatric individuals 6 to 17 years
of age.
Source: FDA website
|
New Drug | 04-02-21 |
Roszet
The Food and Drug Administration (FDA)
approved Roszet® (rosuvastatin calcium/ezetimibe
tablets) as
an adjunct to diet in individuals with primary
non-familial hyperlipidemia to reduce low-density
lipoprotein cholesterol
(LDL-C) and alone or as an adjunct to other LDL-C
lowering therapies in individuals with homozygous
familial hypercholesterolemia
(HoFH) to reduce LDL-C. Source: FDA website
|
New Formulation | 03-23-21 |
Sarclisa
The Food and Drug Administration (FDA)
approved Sarclisa® (isatuximab injection) in
combination with
carfilzomib and dexamethasone, for the treatment of
adults with relapsed or refractory multiple myeloma
(RRMM) who have
received one to three prior lines of therapy. Source:
FDA website
|
New Indication | 03-31-21 |
Telmisartan
Alembic Pharmaceuticals announced a
voluntary recall of one lot of telmisartan tablets 20 mg
due
to a 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/alembic-pharmaceuticals-limited-issues-voluntary-nationwide-recall-telmisartan-tablets-usp-20-mg-due
Source: FDA website
|
Drug Recall | 03-25-21 |
Tyvaso
The Food and Drug Administration (FDA)
approved Tyvaso® (treprostinil oral inhalation
solution) for
the treatment of individuals with pulmonary hypertension
associated with interstitial lung disease (PH-ILD; WHO
Group 3)
to improve exercise ability. Source: FDA website
|
New Indication | 03-31-21 |
Vyxeos
The Food and Drug Administration (FDA)
approved Vyxeos® (daunorubicin/cytarabine injection)
to treat
newly-diagnosed therapy-related acute myeloid leukemia
(t-AML) or AML with myelodysplasia-related changes
(AML-MRC) in
pediatric individuals aged one year and older. Source:
FDA website
|
Expanded Indication | 03-30-21 |
Zegalogue
The Food and Drug Administration (FDA)
approved Zegalogue® (dasiglucagon injection) for the
treatment
of severe hypoglycemia in pediatric and adult
individuals with diabetes aged 6 years and above.
Source: FDA website
|
New Drug | 03-22-21 |
Trodelvy
The Food and Drug Administration (FDA)
approved Trodelvy® (sacituzumab govitecan-hziy
injection) for use in adults with locally advanced or
metastatic urothelial cancer (UC) who have previously
received a platinum-containing chemotherapy and either a
programmed death receptor-1 (PD-1) or a programmed
death-ligand 1 (PD-L1) inhibitor. Source: FDA website
|
New Indication | 04-13-21 |
Opdivo
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab injection) in
combination with certain types of chemotherapy, for the
initial treatment of individuals with advanced or
metastatic gastric cancer, gastroesophageal junction
cancer and esophageal adenocarcinoma. Source: FDA
website
|
New Indication | 04-16-21 |
Ragwitek
The Food and Drug Administration (FDA)
approved Ragwitek® (short ragweed pollen allergen
extract tablet for sublingual use) to include
individuals 5 to 17 years of age for the treatment of
short ragweed pollen-induced allergic rhinitis. Source:
FDA website
|
New Indication | 04-19-21 |
Evekeo ODT
The Food and Drug Administration (FDA)
approved Evekeo ODT® (amphetamine sulfate orally
disintegrating tablets) to include individuals 3 to 5
years of age for the treatment of attention deficit
hyperactivity disorder (ADHD). Source: FDA website
|
New Indication | 04-16-21 |
Diovan
The Food and Drug Administration (FDA)
approved Diovan® (valsartan tablets) to include
individuals 1 to 5 years of age for the treatment of
hypertension. Source: FDA website
|
New Indication | 04-19-21 |
Natroba
The Food and Drug Administration (FDA)
approved Natroba™ (spinosad topical suspension)
for the treatment of scabies infestations in individuals
4 years of age and older. Source: FDA website
|
New Indication | 04-28-21 |
Ferriprox
The Food and Drug Administration (FDA)
approved Ferriprox® (deferiprone tablets and oral
solution) for the treatment of transfusional iron
overload due to sickle cell disease (SCD) or other
anemias in adult and pediatric individuals 3 years of
age and older. Source: FDA website
|
New Indication | 04-30-21 |
Farxiga
The Food and Drug Administration (FDA)
approved Farxiga® (dapagliflozin tablets) to include
reducing the risk of kidney function decline, kidney
failure, cardiovascular (CV) death and hospitalization
for heart failure (HF) in adults with chronic kidney
disease (CKD) who are at risk of disease progression.
Source: FDA website
|
New Indication | 04-30-21 |
Keytruda
The Food and Drug Administration (FDA)
approved Keytruda® (pembrolizumab injection) in
combination with trastuzumab, fluoropyrimidine- and
platinum-containing chemotherapy for the first-line
treatment of individuals with locally advanced
unresectable or metastatic HER2 positive gastric or
gastroesophageal junction (GEJ) adenocarcinoma. Source:
FDA website
|
New Indication | 05-05-21 |
Kloxxado
The Food and Drug Administration (FDA)
approved Kloxxado™ (naloxone hydrochloride nasal
spray) for the emergency treatment of known or suspected
opioid overdose, as manifested by respiratory and/or
central nervous system depression. Source: FDA website
|
New Formulation | 04-29-21 |
Nextstellis
The Food and Drug Administration (FDA)
approved Nextstellis® (drospirenone/estetrol
tablets) for use by females of reproductive potential to
prevent pregnancy. Source: FDA website
|
New Drug | 04-15-21 |
Jemperli
The Food and Drug Administration (FDA)
approved Jemperli (dostarlimab-gxly injection) for the
treatment of adults with mismatch repair deficient
recurrent or advanced endometrial cancer, as determined
by an FDA-approved test, that has progressed on or
following prior treatment with a platinum-containing
regimen. Source: FDA website
|
New Drug | 04-22-21 |
Zynlonta
The Food and Drug Administration (FDA)
approved Zynlonta™ (loncastuximab tesirine-lpyl
injection) for the treatment of adults with relapsed or
refractory large B-cell lymphoma after two or more lines
of systemic therapy, including diffuse large B-cell
lymphoma (DLBCL) not otherwise specified, DLBCL arising
from low grade lymphoma, and high-grade B-cell lymphoma.
Source: FDA website
|
New Drug | 04-23-21 |
NP Thyroid
Acella Pharmaceuticals announced a
voluntary recall of certain lots of NP Thyroid® (15
mg, 30 mg, 60 mg, 90 mg, and 120 mg
levothyroxine/liothyronine tablets) due to sub potency.
Contact your healthcare provider with questions. More
details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-certain-lots-np-thyroidr-thyroid-0
Source: FDA website
|
Drug Recall | 05-01-21 |
Opdivo
The Food and Drug Administration (FDA)
approved Opdivo® (nivolumab injection) for
individuals with completely resected esophageal or
gastroesophageal junction (GEJ) cancer with residual
pathologic disease who have received neoadjuvant
chemoradiotherapy. Source: FDA website
|
New Indication | 05-20-21 |
Levothyroxine sodium
The Food and Drug Administration (FDA)
approved Levothyroxine sodium 100 mcg/mL intravenous
solution for the treatment of myxedema coma. Source: FDA
website
|
New Formulation | 05-17-21 |
Zynrelef
The Food and Drug Administration (FDA)
approved ZynrelefTM (bupivacaine/meloxicam)
extended-release solution for use in adults for soft
tissue or periarticular instillation to produce
postsurgical analgesia for up to 72 hours after
bunionectomy, open inguinal herniorrhaphy, and total
knee arthroplasty. Source: FDA website
|
New Drug | 05-12-21 |
Empaveli
The Food and Drug Administration (FDA)
approved EmpaveliTM (pegcetacoplan injection) for the
treatment of adults with paroxysmal nocturnal
hemoglobinuria. Source: FDA website
|
New Drug | 05-14-21 |
Rybrevant
The Food and Drug Administration (FDA)
approved RybrevantTM (amivantamab-vmjw injection) for
the treatment of adults with locally advanced or
metastatic NSCLC with EGFR exon 20 insertion mutations,
as detected by an FDA-approved test, whose disease has
progressed on or after platinum-based chemotherapy.
Source: FDA website
|
New Drug | 05-21-21 |
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 |
Novo Nordisk Insulins
Novo Nordisk announced a voluntary
recall of 1,468 product samples of Levemir® (insulin
detemir injection), Tresiba® (insulin degludec
injection), Fiasp® (insulin aspart injection), Novolog®
(insulin aspart injection), and Xultophy® (insulin
degludec/liraglutide injection) because they were stored
at temperatures below storage requirements. Contact your
healthcare provider with questions. More details may be
viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novo-nordisk-issues-voluntary-nationwide-recall-levemirr-tresibar-fiaspr-novologr-and-xultophyr
Source: FDA website
|
Drug Recall | 05-10-21 |
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 |
Cosentyx
The Food and Drug Administration (FDA)
approved Cosentyx® (secukinumab injection) to include
treating moderate-to-severe plaque psoriasis in
individuals as young as six years old who are candidates
for systemic therapy or phototherapy. Source: FDA
website
|
Expanded Indication | 05-28-21 |
Ultomiris
The Food and Drug Administration (FDA)
approved Ultomiris® (ravulizumab injection) to treat
individuals aged one month and older with paroxysmal
nocturnal hemoglobinuria (PNH). Source: FDA website
|
Expanded Indication | 06-07-21 |
Lybalvi
The Food and Drug Administration (FDA)
approved Lybalvi™ (olanzapine/samidorphan tablets)
for the treatment of schizophrenia and bipolar 1
disorder in adults. Source: FDA website
|
New Drug | 05-28-21 |
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 adults.
Source: FDA website
|
New Drug | 06-04-21 |
Tembexa
The Food and Drug Administration (FDA)
approved Tembexa® (brincidofovir tablets and oral
suspension) for the treatment of human smallpox disease
in adult and pediatric individuals, including neonates.
Source: FDA website
|
New Drug | 06-04-21 |
Truseltiq
The Food and Drug Administration (FDA)
approved Truseltiq™ (infilgratinib capsules) for
the treatment of adults with
previously treated, unresectable locally advanced or
metastatic
cholangiocarcinoma with a fibroblast growth factor
receptor 2 (FGFR2)
fusion or other rearrangement as detected by an
FDA-approved test. Source: FDA website
|
New Drug | 05-28-21 |
Ryplazim
The Food and Drug Administration (FDA)
approved Ryplazim® (plasminogen injection) for the
treatment of individuals with plasminogen deficiency
type 1. Source: FDA website
|
New Drug | 06-04-21 |
Brexafemme
The Food and Drug Administration (FDA)
approved Brexafemme® (ibrexafungerp tablets) for the
treatment of adult and post-menarchal pediatric females
with vulvovaginal candidiasis (VVC). Source: FDA website
|
New Drug | 06-01-21 |
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 |
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 |
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 |
Aduhelm
The Food and Drug Administration (FDA)
approved Aduhelm™ (aducanumab-avwa injection) for
the treatment of Alzheimer's disease. Source: FDA
website
|
New Drug | 06-07-21 |
Trikafta
The Food and Drug Administration (FDA) approved Trikafta®
(elexacaftor/tezacaftor/ivacaftor tablets)
to include children with cystic fibrosis (CF) ages 6 through 11 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 | 06-08-21 |
Epclusa
The Food and Drug Administration (FDA) approved Epclusa®
(sofosbuvir/velpatasvir tablets and oral pellets) for the treatment of chronic
hepatitis C virus (HCV) in children as young as 3 years of age, regardless of
HCV genotype or liver disease severity. Source: FDA website
|
Expanded Indication | 06-10-21 |
Mavyret
The Food and Drug Administration (FDA) approved Mavyret®
(glecaprevir/pibrentasvir tablet and oral pellets) for the treatment of chronic
hepatitis C virus (HCV) in children as young as 3 years of age, regardless of
HCV genotype or liver disease severity. Source: FDA website
|
Expanded Indication | 06-10-21 |
Ayvakit
The Food and Drug Administration (FDA) approved Ayvakit®
(avapritinib) for adults with advanced systemic mastocytosis (AdvSM), including
those with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an
associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). Source: FDA website
|
New Indication | 06-16-21 |
Soaanz
The Food and Drug Administration (FDA) approved Soaanz®
(torsemide tablets) in adults for the treatment of edema associated with heart
failure or renal disease. Source: FDA website
|
New Formulation | 06-14-21 |
Prevnar 20
The Food and Drug Administration (FDA) approved Prevnar 20™
(pneumococcal 20-valent conjugate vaccine) for the prevention of invasive disease
and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes in adults
ages 18 years and older. Source: FDA website
|
New Formulation | 06-08-21 |
Metformin
Viona Pharmaceuticals announced a voluntary recall of two lots
of metformin hydrochloride extended-release 750 mg tablets due to the detection of
nitrosodimethylamine (NDMA) impurities above acceptable daily limits. 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
Source: FDA website
|
Drug Recall | 06-13-21 |
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of
individuals with locally advanced cutaneous squamous cell carcinoma (cSCC) that cannot be cured by surgery or radiation. Source: FDA website
|
New Indication | 07-01-21 |
Padcev
The Food and Drug Administration (FDA) approved Padcev® (enfortumab vedotin-ejfv injection)
for adults with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy
and have previously received one or more prior lines of therapy. Source: FDA website
|
New Indication | 07-09-21 |
Solosec
The Food and Drug Administration (FDA) approved Solosec® (secnidazole oral granules)
for the treatment of trichomoniasis in adults. Source: FDA website
|
New Indication | 06-30-21 |
Toviaz
The Food and Drug Administration (FDA) approved Toviaz® (fesoterodine fumarate extended-release tablets)
for the treatment of neurogenic detrusor overactivity (NDO) in pediatric individuals 6 years of age and older and weighing
greater than 25 kg. Source: FDA website
|
New Indication | 06-17-21 |
Pradaxa
The Food and Drug Administration (FDA) approved Pradaxa® (dabigatran etexilate oral pellets and capsules)
to treat children 3 months to less than 12 years old with venous thromboembolism directly after they have been
treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa to
prevent recurrent clots among individuals 3 months to less than 12 years old who completed treatment for
their first venous thromboembolism. Source: FDA website
|
New Formulation/Expanded Indication | 06-21-21 |
Verkazia
The Food and Drug Administration (FDA) approved Verkazia™ (cyclosporine ophthalmic emulsion) for the treatment of vernal
keratoconjunctivitis (VKC) in children and adults. Source: FDA website
|
New Drug | 06-23-21 |
Rylaze
The Food and Drug Administration (FDA) approved Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn)
for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL)
or lymphoblastic lymphoma (LBL) in pediatric and adult individuals one month and older who have developed
hypersensitivity to E. coli-derived asparaginase. Source: FDA website
|
New Drug | 06-30-21 |
Kerendia
The Food and Drug Administration (FDA) approved Kerendia® (finerenone tablets) to reduce the risk of kidney function decline,
kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic
kidney disease associated with type 2 diabetes. Source: FDA website
|
New Drug | 07-09-21 |
DeRoyal Industries
DeRoyal Industries announced a voluntary recall of surgical procedure packs due to the packs containing 1%
lidocaine that has been mislabeled as 0.5% bupivacaine. Contact your healthcare provider with questions.
More details may be viewed at: https://www.fda.gov/medical-devices/medical-device-recalls/deroyal-industries-recalls-surgical-procedure-packs-mislabeled-lidocaine
Source: FDA website
|
Drug Recall | 06-25-21 |
Topotecan
Teva Pharmaceuticals announced a voluntary recall of one lot of topotecan 4 mg/1 mL injection due to reports of particulates.
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-one-lot-topotecan-injection-4-mg4-ml-1-mgml-due-presence
Source: FDA website
|
Drug Recall | 07-01-21 |
Avid Medical
Avid Medical announced a voluntary recall of medical convenience kits that include the BD/Carefusion Chloraprep™ 3 mL
applicator due to risk of fungal contamination. Contact your healthcare provider with questions.
More details may be viewed at: https://www.fda.gov/medical-devices/medical-device-recalls/avid-medical-recalls-medical-convenience-kits-risk-fungal-contamination
Source: FDA website
|
Drug Recall | 06-25-21 |
Chantix
Pfizer announced a voluntary recall of nine lots of the smoking cessation drug Chantix® (varenicline tablets)
due to potential levels of a nitrosamine impurity, called N-nitroso-varenicline, above the Food and Drug
Administration (FDA) acceptable intake limit. Contact your healthcare provider with questions. More details may be viewed
at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-patients-voluntary-recall-varenicline-chantix-warehouse
Source: FDA website
|
Drug Recall | 07-02-21 |
Darzalex Faspro
The Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab/hyaluronidase-fihj injection) in combination with pomalidomide and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. Source: FDA website
|
Expanded Indication | 07-09-21 |
ArmonAir Digihaler
The Food and Drug Administration (FDA) approved ArmonAir® Digihaler® (fluticasone propionate oral inhaler) for the maintenance treatment of asthma as prophylactic therapy in pediatric individuals aged 4 to 11 years. Source: FDA website
|
Expanded Indication | 07-09-21 |
Prograf
The Food and Drug Administration (FDA) approved Prograf® (tacrolimus injection, capsule, and oral suspension) for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and pediatric individuals receiving lung transplantation. Source: FDA website
|
Expanded Indication | 07-16-21 |
Vaxneuvance
The Food and Drug Administration (FDA) approved Vaxneuvance™ (pneumococcal 15-valent conjugate vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. Source: FDA website
|
New Formulation | 07-16-21 |
Rezurock
The Food and Drug Administration (FDA) approved Rezurock™ (belumodsudil tablets) for the treatment of adult and pediatric individuals 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. Source: FDA website
|
New Drug | 07-16-21 |
Fexinidazole
The Food and Drug Administration (FDA) approved Fexinidazole tablets for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in individuals 6 years of age and older and weighing at least 20 kg. Source: FDA website
|
New Drug | 07-16-21 |
Innoveix Pharmaceuticals
Innoveix Pharmaceuticals announced a voluntary recall of all lots of sterile compounded drug products within expiry due to a lack of assurance of sterility. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/innoveix-pharmaceuticals-inc-issues-voluntary-recall-all-sterile-compounded-drug-products-due-lack-0 Source: FDA website
|
Drug Recall | 07-14-21 |
Bydureon; Bydureon Bcise
The Food and Drug Administration (FDA) approved Bydureon™ (exenatide extended-release for injectable suspension) and Bydureon® BCise™ (exenatide extended-release injectable suspension) to be used in addition to diet and exercise to improve glycemic control in pediatric individuals 10 years or older with type 2 diabetes. Source: FDA website
|
Expanded Indication | 07-22-21 |
Octagam 10%
The Food and Drug Administration (FDA) approved Octagam® 10% (immune globulin, human, injection) for the treatment of adult dermatomyositis. Source: FDA website
|
New Indication | 07-20-21 |
Bylvay
The Food and Drug Administration (FDA) approved Bylvay™ (odevixibat oral capsules and pellets) for the treatment of pruritus (moderate to severe itching) in individuals with progressive familial intrahepatic cholestasis (PFIC) 3 months of age or older. Source: FDA website
|
New Drug | 07-20-21 |
Chantix
Pfizer announced an expansion of a previous voluntary recall of Chantix™ (varenicline tablets) to 12 lots due to the presence of N-nitroso-varenicline above the acceptable limit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-issues-voluntary-nationwide-recall-twelve-lots-chantixr-varenicline-tablets-due-n-nitroso Source: FDA website
|
Drug Recall | 07-19-21 |
Dalvance
The Food and Drug Administration (FDA) approved Dalvance® (dalbavancin injection) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric individuals from birth. Source: FDA website
|
Expanded Indication | 07-22-21 |
Shingrix
The Food and Drug Administration (FDA) approved Shingrix (zoster vaccine recombinant adjuvanted suspension for intramuscular injection) in adults aged 18 years and older who are or will be at increased risk of herpes zoster due to immunodeficiency or immunosuppression caused by known disease or therapy. Source: FDA website
|
Expanded Indication | 07-23-21 |
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of individuals with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. Source: FDA website
|
Expanded Indication | 07-26-21 |
Botox
The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA injection) to include 8 new muscles for the treatment of upper limb spasticity in adults, along with the use of ultrasound as a muscle localization technique in adult spasticity. Source: FDA website
|
Expanded Indication | 07-28-21 |
Drizalma Sprinkle
The Food and Drug Administration (FDA) approved Drizalma SprinkleTM (duloxetine hydrochloride delayed release capsules) for the treatment of fibromyalgia in adults. Source: FDA website
|
New Indication | 07-23-21 |
Nucala
The Food and Drug Administration (FDA) approved Nucala® (mepolizumab injection) as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults 18 years of age and older with inadequate response to nasal corticosteroids. Source: FDA website
|
New Indication | 07-29-21 |
Twyneo
The Food and Drug Administration (FDA) approved Twyneo® (tretinoin/benzoyl peroxide topical cream) for the treatment of acne vulgaris in adults and pediatric individuals nine years of age and older. Source: FDA website
|
New Formulation | 07-26-21 |
Pepaxto
The Food and Drug Administration (FDA) is alerting consumers and health care providers that a clinical trial evaluating Pepaxto® (melphalan flufenamide injection) with dexamethasone to treat individuals with multiple myeloma showed an increased risk of death. The FDA continues to evaluate this issue and will provide an update when new information is available. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-about-clinical-trial-results-showing-increased
|
Drug Warning | 07-28-21 |
Xywav
The Food and Drug Administration (FDA) approved Xywav®
(calcium, magnesium, potassium, and sodium oxybates oral solution)
for idiopathic hypersomnia (IH) in adults. Source: FDA website
|
New Indication | 08-12-21 |
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection)
for the adjuvant treatment of individuals with urothelial carcinoma (UC) who are at
high risk of recurrence after undergoing radical resection. Source; FDA website
|
New Indication | 08-19-21 |
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination
with lenvatinib for the first-line treatment of adults with advanced renal cell carcinoma (RCC). Source: FDA website
|
Expanded Indication | 08-10-21 |
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 |
Uptravi
The Food and Drug Administration (FDA) approved Uptravi® (selexipag injection for intravenous use)
for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults with WHO functional
class (FC) II–III, who are temporarily unable to take oral therapy. Source: FDA website
|
New Formulation | 07-30-21 |
Ticovac
The Food and Drug Administration (FDA) approved Ticovac™ (tick-borne encephalitis vaccine injection)
for active immunization to prevent tick-borne encephalitis (TBE) in individuals 1 year of age and older. Source: FDA website
|
New Vaccine | 08-13-21 |
Saphnelo
The Food and Drug Administration (FDA) approved Saphnelo™ (anifrolumab-fnia injection)
for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE),
who are receiving standard therapy. Source: FDA website
|
New Drug | 07-30-21 |
Nexviazyme
The Food and Drug Administration (FDA) approved Nexviazyme® (avalglucosidase alfa-ngpt injection)
for the treatment of individuals 1 year of age and older with late-onset Pompe disease. Source: FDA website
|
New Drug | 08-06-21 |
Welireg
The Food and Drug Administration (FDA) approved Welireg™ (belzutifan tablets)
for treatment of adults with von Hippel-Lindau (VHL) disease who require therapy
for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas,
or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Source: FDA website
|
New Drug | 08-13-21 |
Atovaquone
KVK Tech announced a voluntary recall of two lots of atovaquone oral suspension
750 mg/5 mL due to complaints of unusual grittiness. 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-atovaquone-oral-suspension-usp-750-mg5ml-due Source: FDA website
|
Drug Recall | 08-10-21 |
Sodium bicarbonate
SterRx announced a voluntary recall of three lots of sodium bicarbonate 5% dextrose injection
150 mEq per 1,000 mL due to waterborne microbial contamination. Contact your healthcare provider with questions.
More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sterrx-llc-issues-voluntary-nationwide-recall-sodium-bicarbonate-5-dextrose-injection-150meq-1000-ml Source: FDA website
|
Drug Recall | 08-11-21 |
Chantix
Pfizer announced a voluntary recall of an additional four lots of the smoking cessation agent
Chantix® (varenicline tablets) due to the presence of a nitrosamine, N-nitroso-varenicline,
above the Pfizer established Acceptable Daily Intake (ADI) level. Contact your healthcare provider with questions.
More details may be viewed at:https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-include-four-additional-lots-chantixr-varenicline-tablets Source: FDA website
|
Drug Recall | 08-17-21 |
Xarelto
The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban tablets)
in combination with aspirin to reduce the risk of major thrombotic vascular events
in individuals with peripheral artery disease (PAD), including patients who have
recently undergone a lower extremity revascularization procedure due to symptomatic PAD. Source: FDA website
|
New Indication | 08-23-21 |
Tibsovo
The Food and Drug Administration (FDA) approved TIbsovo® (ivosidenib tablets) for adults
with previously treated, locally advanced or metastatic cholangiocarcinoma with an
isocitrate dehydrogenase-1 (IDH1) mutation as detected by a Food and Drug Administered (FDA)-approved test. Source: FDA website
|
New Indication | 08-25-21 |
Skytrofa
The Food and Drug Administration (FDA) approved Skytrofa® (lonapegsomatropin-tcgd injection)
to treat pediatric individuals age one year and older who weigh at least 11.5 kg (25.4 pounds)
and have short stature due to inadequate secretion of endogenous growth hormone. Source: FDA website
|
New Formulation | 08-25-21 |
Korsuva
The Food and Drug Administration (FDA) approved Korsuva™ (difelikefalin injection)
for the treatment of moderate-to-severe pruritus associated with chronic kidney
disease (CKD-aP) in adults undergoing hemodialysis (HD). Source: FDA website
|
New Drug | 08-23-21 |
Briviact
The Food and Drug Administration (FDA) approved Briviact® (brivaracetam tablets, oral solution, and injection)
to include treatment of partial-onset seizures in individuals 1 month of age and older. Source: FDA website
|
Expanded Indication | 08-27-21 |
Brukinsa
The Food and Drug Administration (FDA) approved Brukinsa® (zanubrutinib capsules)
for adults with Waldenström's macroglobulinemia (WM). Source: FDA website
|
New Indication | 08-31-21 |
Invega Hafyera
The Food and Drug Administration (FDA) approved Invega Hafyera™ (paliperidone palmitate injection)
twice-yearly injectable for the treatment of schizophrenia in adults. Source: FDA website
|
New Formulation | 08-30-21 |
Trudhesa
The Food and Drug Administration (FDA) approved Trudhesa™ (dihydroergotamine mesylate nasal inhalation)
for the acute treatment of migraine with or without aura in adults. Source: FDA website
|
New Formulation | 09-03-21 |
Lidocaine
Teligent announced a voluntary recall of one lot of lidocaine HCL topical solution 4% due to super potency.
Contact your healthcare provider with questions. More details may be viewed at:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teligent-pharma-incs-issues-voluntary-recall-lidocaine-hcl-topical-solution-4-lot-14218-exp-092022 Source: FDA website
|
Drug Recall | 09-03-21 |
Janus kinase (JAK) inhibitors
The Food and Drug Administration (FDA) is requiring revisions to the Boxed Warning for
Xeljanz®/Xeljanz XR® (tofacitinib tablets), Olumiant® (baricitinib tablets) and Rinvoq™
(upadacitinib tablets) to include information about the risks of serious heart-related events,
cancer, blood clots, and death. Contact your healthcare provider with questions. More details may be viewed at
:https://www.fda.gov/safety/medical-product-safety-information/janus-kinase-jak-inhibitors-drug-safety-communication-fda-requires-warnings-about-increased-risk?utm_medium=email&utm_source=govdelivery Source: FDA website
|
Drug Recall | 09-03-21 |
Brukinsa
The Food and Drug Administration (FDA) approved Brukinsa® (zanubrutinib capsules)
for the treatment of adults with relapsed or refractory marginal zone lymphoma (MZL)
who have received at least one anti-CD20-based regimen. Source: FDA website
|
New Indication | 09-14-21 |
Exkivity
The Food and Drug Administration (FDA) approved Exkivity™ (mobocertinib capsules)
for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC)
with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by a FDA-approved test,
whose disease has progressed on or after platinum-based chemotherapy. Source: FDA website
|
New Drug | 09-15-21 |
Aminosyn II 15%
ICU Medical announced a voluntary recall of one lot of Aminosyn® (amino acids injection)
II 15% 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/icu-medical-issues-voluntary-nationwide-recall-aminosyn-ii-15-amino-acid-injection-sulfite-free-iv Source: FDA website
|
Drug Recall | 09-09-21 |
Chantix
The Food and Drug Administration (FDA) announced a voluntary recall to include all lots of Chantix® (varenicline tablets)
due to the presence of unacceptable N-nitroso-varenicline levels. Contact your healthcare provider with questions.
More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-include-all-lots-chantixr-varenicline-tablets-due-n Source: FDA website
|
Drug Recall | 09-17-21 |
Firvanq
Azurity Pharmaceuticals announced a voluntary recall of one lot of Firvanq® (vancomycin hydrochloride for oral solution)
due to a mix-up of the diluent included in the kit. Contact your healthcare provider with questions.
More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/azurity-pharmaceuticals-inc-issues-voluntary-nationwide-recall-one-lot-firvanqr-vancomycin
|
Drug Recall | 09-09-21 |
Ruzurgi
Jacobus Pharmaceutical Company announced a voluntary recall of 3 lots of Ruzurgi® (amifampridine10 mg tablets)
due to yeast, mold, and bacterial contamination based on laboratory test results. Contact your healthcare provider with questions.
More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jacobus-pharmaceutical-company-inc-issues-voluntary-worldwide-recall-ruzurgir-amifampridine-10-mg Source: FDA website
|
Drug Recall | 09-15-21 |
Greenpark Compounding Pharmacy
The Food and Drug Administration (FDA) alerted consumers and healthcare providers not to use compounded products
intended to be sterile that were produced and distributed in the United States by Prescription Labs doing business
as Greenpark Compounding Pharmacy due to 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-alerts-patients-and-health-care-professionals-not-use-compounded-products-intended-be-sterile?utm_medium=email&utm_source=govdelivery Source: FDA website
|
Drug Warning | 09-17-21 |
Cabometyx
The Food and Drug Administration (FDA) approved Cabometyx® (cabozantinib tablets)
for the treatment of adult and pediatric individuals 12 years of age and older
with locally advanced or metastatic differentiated thyroid cancer (DTC) that
has progressed following prior vascular endothelial growth factor receptor
(VEGFR)-targeted therapy and who are radioactive iodine-refractory or ineligible. Source: FDA website
|
New Indication | 09-17-21 |
Jakafi
The Food and Drug Administration (FDA) approved Jakafi® (ruxolitinib tablets) for the treatment
of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy
in adult and pediatric individuals 12 years and older. Source: FDA website
|
New Indication | 09-22-21 |
Lexette
The Food and Drug Administration (FDA) approved Lexette™ (halobetasol propionate topical foam)
to include individuals 12 years of age and older with plaque psoriasis. Source: FDA website
|
Expanded Indication | 08-18-21 |
Opzelura
The Food and Drug Administration (FDA) approved Opzelura™ (ruxolitinib cream) for the short-term
and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised
individuals 12 years of age and older whose disease is not adequately controlled with topical prescription
therapies or when those therapies are not advisable. Source: FDA website
|
New Formulation | 09-21-21 |
Tivdak
The Food and Drug Administration (FDA) approved Tivdak™ (tisotumab vedotin-tftv for injection)
for the treatment of adults with recurrent or metastatic cervical cancer with disease progression
on or after chemotherapy. Source: FDA website
|
New Drug | 09-20-21 |
Cefazolin
IntegraDose Compounding Services announced a voluntary recall of nine lots of cefazolin 2 gram in 20 mL syringe
for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance.
Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/integradose-compounding-services-llc-issues-voluntary-nationwide-recall-cefazolin-injection-products?utm_medium=email&utm_source=govdelivery Source: FDA website
|
Drug Recall | 09-22-21 |
Repatha
The Food and Drug Administration (FDA) approved Repatha® (evolocumab injection)
as an add-on treatment to diet alone or together with certain other therapies for
individuals aged 10 years and older with heterozygous familial hypercholesterolemia
(HeFH) and homozygous familial hypercholesterolemia (HoFH). Source: FDA website
|
New Indication | 09-24-21 |
Erbitux
The Food and Drug Administration (FDA) approved Erbitux® (cetuximab injection)
in combination with Braftovi® (encorafenib capsules) for the treatment of adults
with metastatic colorectal cancer with a BRAF V600E mutation, as detected by a Food and Drug Administration
(FDA)-approved test, after prior therapy. Source: FDA website
|
New Indication | 09-24-21 |
Qulipta
The Food and Drug Administration (FDA) approved Qulipta™ (atogepant tablets)
for the preventive treatment of episodic migraine in adults. Source: FDA website
|
New Drug | 09-28-21 |
Livmarli
The Food and Drug Administration (FDA) approved Livmarli™ (maralixibat oral solution)
for the treatment of cholestatic pruritus in individuals with Alagille syndrome one year of age and older. Source: FDA website
|
New Drug | 09-29-21 |
Glucagon
Eli Lilly and Company announced a voluntary recall of one lot of Glucagon™ (glucagon for injection)
Emergency Kit due to a report that the vial was in liquid form instead of the powder form.
Contact your healthcare provider with questions. More details may be viewed
at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eli-lilly-and-company-issues-voluntary-nationwide-recall-one-lot-glucagonr-emergency-kit-due-loss Source: FDA website
|
Drug Recall | 09-27-21 |
Tecartus
The Food and Drug Administration (FDA) approved Tecartus® (brexucabtagene autoleucel injection)
for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Source: FDA website
|
New Indication | 10-01-21 |
Zercapli
The Food and Drug Administration (FDA) approved Zercapli (sertraline hydrochloride capsules)
for the treatment of major depressive disorder in adults and for the treatment of obsessive-compulsive
disorder in adults and pediatric individuals 6 years and older. Source: FDA website
|
New Indication | 10-04-21 |
Tavneos
The Food and Drug Administration (FDA) approved Tavneos™ (avacopan capsules) as an adjunctive treatment
for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis
(also known as ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis
(GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy. Source: FDA website
|
New Drug | 10-08-21 |
Dextenza
The Food and Drug Administration (FDA) approved Dextenza® (dexamethasone intraocular suspension) for the treatment of ocular itching associated with allergic conjunctivitis. Source: FDA website
|
New Indication | 10-11-21 |
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) ) in combination with chemotherapy, with or without bevacizumab, for individuals with persistent, recurrent or metastatic cervical cancer whose tumors express programmed death ligand-1 (PD-L1) combined positive score (CPS) ≥1, as determined by a Food and Drug Administration (FDA)-approved test. Source: FDA website
|
New Indication | 10-13-21 |
Verzenio
The Food and Drug Administration (FDA) approved Verzenio® (abemaciclib tablets) approved in combination with endocrine therapy for the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of ≥20% as determined by a Food and Drug Administration (FDA)-approved test. Source: FDA website
|
Expanded Indication | 10-12-21 |
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) for adjuvant treatment following resection and platinum-based chemotherapy in individuals with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have programmed death ligand-1 (PD-L1) expression on ≥ 1% of tumor cells, as determined by a Food and Drug Administration (FDA)-approved test. Source: FDA website
|
Expanded Indication | 10-15-21 |
Biktarvy
The Food and Drug Administration (FDA) approved Biktarvy® (bictegravir/ emtricitabine/tenofovir alafenamide tablets) to include treatment of human immunodeficiency virus (HIV)-1 infected pediatric individuals weighing at least 14 kg. Source: FDA website
|
Expanded Indication | 10-07-21 |
Rethymic
The Food and Drug Administration (FDA) approved Rethymic® (allogeneic processed thymus tissue-agdc surgical implant) for immune reconstitution in children with congenital athymia. Source: FDA website
|
New Drug | 10-08-21 |
Lidocaine 4%
Teligent Pharma announced a voluntary recall of 5 lots of Lidocaine 4% topical solution due to super potency. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teligent-pharma-incs-issues-worldwide-voluntary-recall-lidocaine-hcl-topical-solution-4-due-super Source: FDA website
|
Drug Recall | 10-13-21 |
Irbesartan; Irbesartan/Hydrochlorothiazide
Lupin Pharmaceuticals announced a voluntary recall of all batches of irbesartan tablets and irbesartan/hydrochlorothiazide tablets due to the potential presence of N-nitrosoirbesartan 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-voluntarily-nationwide-recall-all-irbesartan-tablets-and-irbesartan Source: FDA website
|
Drug Recall | 10-14-21 |
Flucelvax Quadrivalent
The Food and Drug Administration (FDA) approved Flucelvax® Quadrivalent (influenza vaccine injection) for active immunization in individuals 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Source: FDA website
|
Expanded Indication | 10-15-21 |
Vimpat
The Food and Drug Administration (FDA) approved Vimpat® (lacosamide tablet, oral solution, and injection) for monotherapy and adjunctive therapy
in the treatment of partial onset seizures in individuals 1 month and older to less than 4 years of age. Source: FDA website
|
Expanded Indication | 10-14-21 |
Zimhi
The Food and Drug Administration (FDA) approved ZimhiTM (naloxone injection) for use in the treatment of opioid overdose. Source: FDA website
|
New Formulation | 10-15-21 |
Seglentis
The Food and Drug Administration (FDA) approved Seglentis (celecoxib/tramadol tablets) for the treatment of acute pain in adults. Source: FDA website
|
New Formulation | 10-18-21 |
Tyrvaya
The Food and Drug Administration (FDA) approved TyrvayaTM (varenicline nasal spray) for the treatment of the signs and symptoms of dry eye disease. Source: FDA website
|
New Drug | 10-15-21 |
Methocarbamol
Bryant Ranch Prepack announced a voluntary recall of one lot of methocarbamol 500 mg due to mislabeling with the incorrect strength. 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-issues-voluntary-nationwide-recall-methocarbamol-500mg-bottles-due-mislabeling Source: FDA website
|
Drug Recall | 10-19-21 |
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for add-on maintenance treatment in moderate-to-severe asthma in children ages 6 to 11 years. Source: FDA website
|
Expanded Indication | 10-20-21 |
Cutaquig
The Food and Drug Administration (FDA) approved Cutaquig® (human immune globulin subcutaneous injection) in pediatric individuals 2 years of age and older for the treatment of primary humoral immunodeficiency. Source: FDA website
|
Expanded Indication | 10-22-21 |
Susvimo
The Food and Drug Administration (FDA) approved SusvimoTM (ranibizumab injection) for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Source: FDA website
|
New Formulation | 10-22-21 |
Xipere
The Food and Drug Administration (FDA) approved XipereTM (triamcinolone acetonide injection for suprachoroidal use) for the treatment of macular edema associated with uveitis. Source: FDA website
|
New Formulation | 10-22-21 |
Vuity
The Food and Drug Administration (FDA) approved VuityTM (pilocarpine 1.25% ophthalmic solution) for the treatment of presbyopia in adults. Source: FDA website
|
New Formulation | 10-28-21 |
Purified Cortrophin Gel
The Food and Drug Administration (FDA) approved Purified Cortrophin® Gel (repository corticotropin injection) for the treatment of rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic disease, respiratory diseases, edematous states, and acute exacerbation of multiple sclerosis. Source: FDA website
|
New Formulation | 11-01-21 |
Scemblix
The Food and Drug Administration (FDA) approved Scemblix® (asciminib tablets) for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs) and for the treatment of adults with Ph+ CML in CP with T315I mutation. Source: FDA website
|
New Drug | 10-29-21 |
Monoject Flush Prefilled Saline Syringes
Aligned Medical Solutions announced a voluntary recall of Cardinal Health's MonojectTM Flush Prefilled Saline Syringes placed into kits due to the potential for the plunger to draw back after air has been expelled allowing for reintroduction of air back into the syringe. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/windstone-medical-packaging-dba-aligned-medical-solutions-issues-nationwide-recall-cardinal-healths Source: FDA website
|
Drug Recall | 10-28-21 |
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the adjuvant treatment of individuals with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. Source: FDA website
|
New Indication | 11-17-21 |
Dyanavel XR
The Food and Drug Administration (FDA) approved Dyanavel® XR (amphetamine extended-release tablets) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals 6 years of age and older. Source: FDA website
|
New Formulation | 11-04-21 |
Eprontia
The Food and Drug Administration (FDA) approved EprontiaTM (topiramate oral solution) as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in individuals 2 years of age or older: adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in individuals 2 years of age and older; and preventive treatment of migraine in individuals12 years of age and older. Source: FDA website
|
New Formulation | 11-05-21 |
Dhivy
The Food and Drug Administration (FDA) approved DhivyTM (carbidopa/levodopa tablets) for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Source: FDA website
|
New Formulation | 11-12-21 |
Besremi
The Food and Drug Administration (FDA) approved Besremi® (ropeginterferon alfa-2b-njft injection) for the treatment of adults with polycythemia vera (PV). Source: FDA source
|
New Drug | 11-12-21 |
Voxzogo
The Food and Drug Administration (FDA) approved VoxzogoTM (vosoritide injection) to increase linear growth in pediatric individuals with achondroplasia who are 5 years of age and older with open epiphyses. Source: FDA website
|
New Drug | 11-19-21 |
SterRx
SterRx announced a voluntary recall of approximately 240 lots of products due to lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sterrx-llc-issues-voluntary-nationwide-recall-certain-sterrx-products Source: FDA website
|
Drug Recall | 11-16-21 |
Injectafer
The Food and Drug Administration (FDA) approved Injectafer® (ferric carboxymaltose injection) for pediatric individuals 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron. Source: FDA website
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Expanded Indication | 11-19-21 |
Darzalex Faspro
The Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj injection) in combination with carfilzomib plus dexamethasone for adults with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. Source: FDA website
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Expanded Indication | 11-30-21 |
Lyvispah
The Food and Drug Administration (FDA) approved Lyvispah (baclofen oral granules) for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Lyvispah may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Source: FDA website
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New Formulation | 11-22-21 |
Livtencity
The Food and Drug Administration (FDA) approved Livtencity (maribavir tablets) for the treatment of adults and pediatric individuals (≥12 years of age and weighing ≥35 kg) with post-transplant |