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
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
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
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
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
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
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
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
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
Gammagard Liquid
The Food and Drug Administration (FDA) approved Gammagard Liquid (immune globulin infusion [human], 10% solution, for intravenous and subcutaneous administration) to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). Source: FDA website
New Indication 1/26/2024
Xolair
The Food and Drug Administration (FDA) approved Xolair® (omalizumab injection for subcutaneous use) for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions (Type I), including reducing the risk of anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjuction with food allergen avoidance. Source: FDA website
New Indication 1/16/2024
Tagrisso
The Food and Drug Administration (FDA) approved Tagrisso® (osimertinib tablets) with platinum-based chemotherapy for people with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Source: FDA website
Expanded Indication 1/16/2024
Acycaz
The Food and Drug Administration (FDA) approved Avycaz® (avibactam sodium/ceftazidime injection for intravenous use) to include the addition of the pediatric population from birth (at least 31 weeks gestational age) to less than 3 months of age for the treatment of complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), including pyelonephritis, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). Source: FDA website
Expanded Indication 1/26/2024
Onivyde
The Food and Drug Administration (FDA) approved Onivyde® (irinotecan liposome injection for intravenous use) with oxaliplatin, fluorouracil, and leucovorin for the first-line treatment of metastatic pancreatic adenocarcinoma. Source: FDA website
Expanded Indication 2/13/2024
Amtagvi
The Food and Drug Administration (FDA) approved Amtagvi (lifileucel suspension for intravenous infusion) for adults with unresectable or metastatic melanoma previously treated with programmed death-1 (PD-1) blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor. Source: FDA website
New Drug 2/16/2024
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Exparel
The Food and Drug Administration (FDA) approved Exparel® (bupivacaine liposome injectable suspension) to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa. Source: FDA website
New Indication 11-10-2023
Voquezna
The Food and Drug Administration (FDA) approved Voquezna® (vonoprazan tablets) for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults and to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults. Source: FDA website
New Indication 11-1-2023
Zituvio
The Food and Drug Administration (FDA) approved ZituvioTM (sitagliptin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Source: FDA website
New Formulation 10-18-2023
Zituvimet
The Food and Drug Administration (FDA) approved Zituvimet (sitagliptin/metformin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Source: FDA website
New Formulation 11-3-2023
Zepbound
The Food and Drug Administration (FDA) approved ZepboundTM (tirzepatide subcutaneous injection) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
  • 30 kg/m2 or greater (obesity) or
  • 27 kg/m2 or greater (overweight) in presence of at least one
  • weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease). Source: FDA website
    New Drug 11-8-2023
    Fruqaqla
    The Food and Drug Administration (FDA) approved FruzaqlaTM (fruquintinib capsules) for the treatment of adults with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy, and, if rat sarcoma virus (RAS) wild-type and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy. Source: FDA website
    New Drug 11-8-2023
    Adzynma
    The Food and Drug Administration (FDA) approved Adzynma (ADAMTS13, recombinant-krhn lyophilized powder for injection, for intravenous use) for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric people with congenital thrombotic thrombocytopenic purpura (cTTP). Source: FDA website
    New Drug 11-9-2023
    Ixchiq
    The Food and Drug Administration (FDA) approved Ixchiq® (Chikungunya vaccine, live, solution for intramuscular injection) for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. Source: FDA website
    New Vaccine 11-10-2023
    Nurse Assist
    Nurse Assist announced a voluntary recall of 0.9% sodium chloride irrigation and sterile water for irrigation due to the potential for a lack of sterility assurance. Contact your healthcare provider for questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nurse-assist-llc-issues-recall-09-sodium-chloride-irrigation-usp-and-sterile-water-irrigation-usp Source: FDA website
    Drug Recall 11-6-2023
    Keytruda
    The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Source: FDA website
    Expanded Indication 11-16-2023
    Xtandi
    The Food and Drug Administration (FDA) approved Xtandi® (enzalutamide tablets) for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). Source: FDA website
    Expanded Indication 11-16-2023
    Wilate
    The Food and Drug Administration (FDA) approved Wilate® (von Willebrand factor/coagulation factor VIII complex [Human]) for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children 6 years of age and older with von Willebrand disease (VWD). Source: FDA website
    Expanded Indication 12-5-2023
    Cresemba
    The Food and Drug Administration (FDA) approved Cresemba® (isavuconazonium sulfate oral capsules and injection) to include treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric people 1 year of age and older. Source: FDA website
    Expanded Indication 12-8-2023
    Jaypirca
    The Food and Drug Administration (FDA) approved Jaypirca® (pirtobrutinib tables) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma-2 (BCL-2) inhibitor. Source: FDA website
    New Indication 12-1-2023
    Alvaiz
    The Food and Drug Administration (FDA) approved AlvaizTM (eltrombopag tablets) for the treatment of thrombocytopenia in adult and pediatric people 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy, thrombocytopenia in adults with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy, and adults with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. Source: FDA website
    New Formulation 11-29-2023
    Augtyro
    The Food and Drug Administration (FDA) approved AugtyroTM (repotrectinib capsules) for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Source: FDA website
    New Drug 11-15-2023
    Truqap
    The Food and Drug Administration (FDA) approved TruqapTM (capivasertib tablets) in combination with fulvestrant injection for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with ≥1 PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on ≥1 endocrine-based regimen(s) in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. Source: FDA website
    New Drug 11-16-2023
    Ryzneuta
    The Food and Drug Administration (FDA) approved Ryzneuta® (efbemalenograstim alfa-vuxw injection) to decrease the incidence of infection, as manifested by febrile neutropenia (FN), in adults with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Source: FDA website
    New Drug 11-16-2023
    Ogsiveo
    The Food and Drug Administration (FDA) approved OgsiveoTM (nirogacestat tablets) for adults with progressing desmoid tumors who require systemic treatment. Source: FDA website
    New Drug 11-27-2023
    Fabhalta
    The Food and Drug Administration (FDA) approved Fabhalta® (iptacopan capsules) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). Source: FDA website
    New Drug 12-5-2023
    Casgevy
    The Food and Drug Administration (FDA) approved CasgevyTM (exagamglogene autotemcel suspension for intravenous infusion) for the treatment of sickle cell disease (SCD) in people 12 years and older with recurrent vaso-occlusive crises (VOCs). Source: FDA website
    New Drug 12-8-2023
    Lyfgenta
    The Food and Drug Administration (FDA) approved Lyfgenia® (lovotibeglogene autotemcel suspension for intravenous infusion) for the treatment of people 12 years of age or older with sickle cell disease and a history of vaso-occlusive events. Source: FDA website
    New Drug 12-8-2023
    Sandimmune
    Novartis announced a voluntary recall of two lots of Sandimmune® (cyclosporine oral solution 100 mg/mL) due to crystal formation observed in some bottles. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-us-nationwide-recall-two-lots-sandimmuner-oral-solution-cyclosporine-oral Source: FDA website
    Drug Recall 11-24-2023
    Vitrakvi
    Bayer announced a voluntary recall of one lot of Vitrakvi® (larotrectinib oral solution 20 mg/mL) due to the presence of bacterial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-issues-voluntary-recall-nationwide-vitrakvir-larotrectinib-oral-solution-20-mgml-due-presence Source: FDA website
    Drug Recall 11-17-2023
    Antiseizure medications
    The Food and Drug Administration (FDA) issued a warning that the antiseizure medications levetiracetam and clobazam can cause a serious reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). The FDA is requiring warnings about this risk to be added to the prescribing information and Medication Guides for these medicines.Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/antiseizure-medicines-keppra-keppra-xr-elepsia-xr-spritam-levetiracetam-and-onfi-sympazan-clobazam Source: FDA website
    Drug Warning 11-28-2023
    BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies
    The Food and Drug Administration (FDA) has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in people who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. The FDA continues to investigate. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/bcma-directed-or-cd19-directed-autologous-chimeric-antigen-receptor-car-t-cell-immunotherapies-fda Source: FDA website
    Drug Warning 11-28-2023
    Keytruda
    The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) with chemoradiotherapy (CRT) for people with FIGO 2014 Stage III-IVA cervical cancer. Source: FDA website
    Expanded Indication 01-12-2024
    Hyqvia
    The Food and Drug Administration (FDA) approved Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase injection) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. Source: FDA website
    New Indication 01-16-2024
    casgevy
    The Food and Drug Administration (FDA) approved CasgevyTM (exagamglogene autotemcel injection) for the treatment of people aged 12 years and older with transfusion-dependent β-thalassemia (TDT). Source: FDA website
    New Indication 01-16-2024
    Zelsuvmi
    The Food and Drug Administration (FDA) approved ZelsuvmiTM (berdazimer topical gel) for the treatment of molluscum contagiosum (MC) in adults and pediatric individuals 1 year of age and older. Source: FDA website
    New Drug 01-05-2024
    Leiters Health
    Leiters Health announced a voluntary recall of 33 lots of vancomycin intravenous (IV) bags, phenylephrine IV bags, and fentanyl IV bags due to the potential for superpotency. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/leiters-health-issues-voluntary-nationwide-recall-vancomycin-iv-bags-phenylephrine-iv-bags-and Source: FDA website
    Drug Recall 01-08-2024
    Certain Type 2 Diabetes and Obesity Medications
    The Food and Drug Administration (FDA) has been evaluating reports of suicidal thoughts or actions in people being treated with glucagon-like peptide-1 receptor agonists for type 2 diabetes or obesity. Preliminary evaluations have not found evidence that use of these medications causes suicidal thoughts or actions. The FDA continues to evaluate the issue. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/certain-type-medicines-approved-type-2-diabetes-and-obesity-drug-safety-communication-update-fdas Source: FDA website
    Drug Warning 01-11-2024
    Piqray
    The Food and Drug Administration (FDA) approved Piqray® (alpelisib tablets) for expanded use in pre and perimenopausal women for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer. Source: FDA website
    Expanded Indication 1-18-2024
    Zynrelef
    The Food and Drug Administration (FDA) approved Zynrelef® (bupivacaine/meloxicam extended-release solution for instillation) to include postsurgical analgesia for up to 72 hours for soft tissue and orthopedic surgical procedures including foot and ankle procedures, and other orthopedic procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided. Source: FDA website
    Expanded Indication 1-23-2024
    Dupixent
    The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for the treatment of pediatric people aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE). Source: FDA website
    Expanded Indication 1-25-2024
    Zenzedi
    Azurity Pharmaceuticals announced a voluntary recall of one lot of Zenzedi® (dextroamphetamine 30 mg tablets) due to a mislabeled package during manufacturing. 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-zenzedir-dextroamphetamine-sulfate Source: FDA website
    Drug Recall 1-26-2024
    Prolia
    The Food and Drug Administration (FDA) has concluded, based on a review of available information, that the osteoporosis medication Prolia® (denosumab injection) increases the risk of severe hypocalcemia, very low blood calcium levels, in people with advanced chronic kidney disease (CKD), especially those on dialysis. Severe hypocalcemia appears to be more common in people with CKD who also have a condition known as mineral and bone disorder (CKD-MBD). The product labeling will be revised. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/prolia-denosumab-drug-safety-communication-fda-adds-boxed-warning-increased-risk-severe-hypocalcemia Source: FDA website
    Drug Warning 1-19-2024