Drug Information

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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
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
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
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
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
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
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
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) to include the pediatric population for the adjuvant treatment of adult and pediatric individuals 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Source: FDA website
Expanded Indication 2/15/2023
Yervoy
The Food and Drug Administration (FDA) approved Yervoy® (ipilimumab injection) to include the pediatric population for the treatment of unresectable or metastatic melanoma in adult and pediatric individuals 12 years and older. Source: FDA website
Expanded Indication 2/15/2023
Austedo XR
The Food and Drug Administration (FDA) approved Austedo® XR (deutetrabenazine extended-release tablets) in adults for tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). Source: FDA website
New Formulation 2/17/2023
Lamzede
The Food and Drug Administration (FDA) approved Lamzede® (velmanase alfa-tycv) for the treatment of non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and pediatric individuals. Source: FDA website
New Drug 2/16/2023
Filspari
The Food and Drug Administration (FDA) approved Filspari™ (sparsentan tablets) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. Source: FDA website
New Drug 2/17/2023
Syfovre
The Food and Drug Administration (FDA) approved Syfovre™ (pegcetacoplan intravitreal injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration. Source: FDA website
New Drug 2/17/2023
Altuviiio
The Food and Drug Administration (FDA) approved Altuviiio™ (antihemophilic factor [recombinant], Fc-VWF-XTEN fusion protein-ehtl], lyophilized powder for solution, for intravenous use) for use in adults and children with hemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding. Source: FDA website
New Drug 2/22/2023
Descovy
The Food and Drug Administration (FDA) approved Descovy® (emtricitabine/tenofovir alafenamide fumarate tablets) to include treatment of human immunodeficiency virus (HIV)-1 infection in pediatric individuals at least 2 years of age and weighing at least 14 kg.Source: FDA website
Expanded Indication 01-07-22
Quviviq
The Food and Drug Administration (FDA) approved Quviviq (daridorexant tablets) for the treatment of adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.Source: FDA website
New Drug 01-07-22
Senna
Lohxa announced a voluntary recall of one lot of Senna Syrup 8.8 mg/5 mL unit-dose cups due to microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lohxa-llc-issues-voluntary-nationwide-recall-senna-syrup-88mg5ml-due-microbial-contamination Source: FDA website
Drug Recall 01-13-22
Metformin
Viona Pharmaceuticals announced a voluntary recall of twenty-three lots of metformin hydrochloride extended-release tablets 750 mg due to detection of N-nitrosamine (NDMA) impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0 Source: FDA website
Drug Recall 01-12-22
Buprenorphine
The Food and Drug Administration (FDA) is warning that dental problems (tooth decay, cavities, oral infection, and loss of teeth) have been reported with medicines containing buprenorphine that are dissolved in the mouth for opioid use disorder and pain. The FDA is requiring a new warning be added to the prescribing information. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/buprenorphine-drug-safety-communication-fda-warns-about-dental-problems-buprenorphine-medicines Source: FDA website
Drug Warning 01-12-22
Rinvoq
The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib tablets) for the treatment of adults and children 12 years of age and older with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Source: FDA website
New Indication 01-14-22
Skyrizi
The Food and Drug Administration (FDA) approved SkyriziTM (risankizumab-rzaa injection) for the treatment of adults with active psoriatic arthritis (PsA). Source: FDA website
New Indication 01-24-22
Veklury
The Food and Drug Administration (FDA) approved Veklury® (remdesivir injection) for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric individuals (12 years of age and older and weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. Source: FDA website
Expanded Indication 01-21-22
Ryaltris
The Food and Drug Administration (FDA) approved RyaltrisTM (olopatadine hydrochloride/mometasone furoate nasal spray) for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric individuals 12 years of age and older. Source: FDA website
New Formulation 01-13-22
Cibinqo
The Food and Drug Administration (FDA) approved CibinqoTM (abrocitinib tablets) for the treatment of adults with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Source: FDA website
New Drug 01-14-22
Semglee
Mylan Pharmaceuticals announced a voluntary recall of one batch of its non-interchangeable Semglee injection due to the potential for a missing label. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-recall-one-batch-semgleer-insulin Source: FDA website
Drug Recall 01-19-22
Solosec
The Food and Drug Administration (FDA) approved Solosec® (secnidazole oral granules) for the treatment of bacterial vaginosis and trichomoniasis caused by Trichomonas vaginalis in individuals 12 years of age and older. Source: FDA website
Expanded Indication 01-26-22
Pifeltro
The Food and Drug Administration (FDA) approved Pifeltro® (doravirine tablets) for the treatment of human immunodeficiency virus (HIV)-1 in pediatric individuals weighing at least 35 kg. Source: FDA website
Expanded Indication 01-27-22
Delstrigo
The Food and Drug Administration (FDA) approved DelstrigoTM (doravirine/lamivudine/tenofovir disoproxil fumarate tablets) for the treatment of human immunodeficiency virus (HIV)-1 in pediatric individuals weighing at least 35 kg. Source: FDA website
Expanded Indication 01-27-22
Vonvendi
The Food and Drug Administration (FDA) approved Vonvendi® (recombinant von Willebrand factor injection) for routine prophylaxis to reduce the frequency of bleeding episodes in individuals with severe Type 3 von Willebrand disease (VWD) receiving on-demand therapy. Source: FDA website
Expanded Indication 01-31-22
Nucala
The Food and Drug Administration (FDA) approved Nucala (mepolizumab 40 mg prefilled syringe injection) as add-on maintenance treatment for children 6 to 11 years of age with severe asthma and with an eosinophilic phenotype. Source: FDA website
New Formulation 01-22-22
Kimmtrak
The Food and Drug Administration (FDA) approved Kimmtrak® (tebentafusp-tebn injection) for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM). Source: FDA website
New Drug 01-26-22
Vabysmo
The Food and Drug Administration (FDA) approved VabysmoTM (faricimab-svoa injection for intravitreal use) for the treatment of adults with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME). Source: FDA website
New Drug 01-28-22
Polymyxin B
AuroMedics Pharma announced a voluntary recall of one lot of polymyxin B for injection due to a product complaint for the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/auromedics-pharma-llc-issues-voluntary-nationwide-recall-polymyxin-b-injection-usp-500000-unit-vial Source: FDA website
Drug Recall 01-28-22
Xigduo XR
The Food and Drug Administration (FDA) approved Xigduo® XR (dapagliflozin/metformin hydrochloride extended-release tablets) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. Source: FDA website
New Indication 02-03-22
Fleqsuvy
The Food and Drug Administration (FDA) approved FleqsuvyTM (baclofen oral suspension) for the treatment of spasticity resulting from multiple sclerosis (MS), particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Source: FDA website
New Formulation 02-04-22
Enjaymo
The Food and Drug Administration (FDA) approved EnjaymoTM (sutimlimab-jome injection) to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD). Source: FDA website
New Drug 02-04-22
Ukoniq
The Food and Drug Administration (FDA) is investigating a possible increased risk of death due to the cancer drug Ukoniq® (umbralisib tablets). The FDA is re-evaluating the risk versus benefit of Ukoniq and is continuing to look at results from the UNITY clinical trial. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/ukoniq-umbralisib-drug-safety-communication-fda-investigating-possible-increased-risk-death-lymphoma Source: FDA website
Drug Warning 02-03-22
Jardiance
The Food and Drug Administration (FDA) approved Jardiance® (empagliflozin tablets) to treat adults with heart failure regardless of left ventricular ejection fraction. Source: FDA website
Expanded Indication 02-24-22
Norliqva
The Food and Drug Administration (FDA) approved Norliqva® (amlodipine oral solution) for the treatment of hypertension in adults and children 6 years and older and for the treatment of coronary artery disease and angiographically documented coronary artery disease in individuals without heart failure or an ejection fraction <40%. Source: FDA website
New Formulation 02-24-22
Aspruzyo Sprinkle
The Food and Drug Administration (FDA) approved Aspruzyo SprinkleTM (ranolazine extended-release oral granules) for the treatment of chronic angina. Source: FDA website
New Formulation 02-28-22
Pyrukynd
The Food and Drug Administration (FDA) approved Pyrukynd® (mitapivat tablets) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. Source: FDA website
New Drug 02-17-22
Carvykti
The Food and Drug Administration (FDA) approved CarvyktiTM (ciltacabtagene autoleucel suspension for intravenous infusion) for the treatment of adults with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Source: FDA website
New Drug 02-28-22
Vonjo
The Food and Drug Administration (FDA) approved VonjoTM (pacritinib capsules) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Source: FDA website
New Drug 02-28-22
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) in combination with platinum-doublet chemotherapy for adults with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting. Source: FDA website
Expanded Indication 03-04-22
Lynparza
The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for the adjuvant treatment of adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Source: FDA website
Expanded Indication 03-11-22
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) as a single agent for individuals with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by a Food and Drug Administration (FDA)-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. Source: FDA website
Expanded Indication 03-21-22
Smoflipid
The Food and Drug Administration (FDA) approved Smoflipid® (lipid injectable emulsion) as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated expanded to include pediatric individuals. Source: FDA website
Expanded Indication 03-22-22
Rinvoq
The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib extended-release tablets) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Source: FDA website
New Indication 03-16-22
Adlarity
The Food and Drug Administration (FDA) approved Adlarity® (donepezil transdermal system) for the treatment of adults with mild, moderate, and severe dementia of the Alzheimer type. Source: FDA website
New Formulation 03-11-22
Xelstrym
The Food and Drug Administration (FDA) approved XelstrymTM (dextroamphetamine transdermal system) for the treatment of attention-deficit/hyperactivity disorder (ADHD) for adults and pediatric individuals 6 years and older. Source: FDA website
New Formulation 03-23-22
Hyftor
The Food and Drug Administration (FDA) approved HyftorTM (sirolimus topical gel) for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric individuals 6 years of age and older. Source: FDA website
New Formulation 03-22-22
Ztalmy
The Food and Drug Administration (FDA) approved Ztalmy® (ganaxolone oral suspension) for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in individuals 2 years of age or older. Source: FDA website
New Drug 03-18-22
Opdualag
The Food and Drug Administration (FDA) approved OpdualagTM (nivolumab/relatlimab-rmbw injection) for the treatment of adult and pediatric individuals 12 years of age or older with unresectable or metastatic melanoma. Source: FDA website
New Drug 03-18-22
Pluvicto
The Food and Drug Administration (FDA) approved PluvictoTM (lutetium Lu 177 vipivotide tetraxetan injection) for the treatment of adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. Source: FDA website
New Drug 03-23-22
Sodium acetate
Fresenius Kabi announced a voluntary recall of seven lots of sodium acetate injection due to the presence of particulate matter.Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-recall-sodium-acetate-injection-usp-due-presence-particulate-matter Source: FDA website
Drug Recall 03-08-22
Quinapril/hydrochlorothiazide
Pfizer announced a voluntary recall of six lots of AccureticTM (quinapril HCL/hydrochlorothiazide) tablets distributed by Pfizer as well as five lots of two authorized generics distributed by Greenstone due to the presence of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuretictm-quinapril-hclhydrochlorothiazide-quinapril-and Source: FDA website
Drug Recall 03-22-22
Orphenadrine citrate
Sandoz announced a voluntary recall of 13 lots of oral orphenadrine citrate 100 mg extended-release tablets due to the presence of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-13-lots-orphenadrine-citrate-100-mg-extended-release-tablets-due Source: FDA website
Drug Recall 03-23-22
Symjepi
Adamis Pharmaceuticals announced a voluntary recall of certain lots of SymjepiTM (epinephrine injection) due to the potential clogging of the needle preventing the dispensing of epinephrine. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adamis-pharmaceuticals-corporation-issues-nationwide-voluntary-recall-symjepir-epinephrine-injection Source: FDA website
Drug Recall 03-22-22
Fintepla
The Food and Drug Administration (FDA) approved Fintepla® (fenfluramine oral solution) for the treatment of seizures associated with Lennox-Gastaut syndrome in individuals two years of age and older. Source: FDA website
New Indication 03-25-22
Cabenuva
The Food and Drug Administration (FDA) approved Cabenuva (cabotegravir extended-release injectable suspension and rilpivirine extended-release injectable suspension) for expanded use of every 2-month dosing regimen to include the treatment of human immunodeficiency virus (HIV)-1 infection in adolescents 12 years of age and older and weighing at least 35 kg. Source: FDA website
Expanded Indication 03-29-22
Vocabria and Edurant
The Food and Drug Administration (FDA) approved Vocabria (cabotegravir tablets) for expanded use in combination with Edurant® (rilpivirine tablets) as an oral, short-term treatment regimen followed by Cabenuva injection dosing regimen for the treatment of human immunodeficiency virus (HIV)-1 virus infection in adolescents 12 years of age and older and weighing at least 35 kg. Source: FDA website
Expanded Indication 03-29-22
Tlando
The Food and Drug Administration (FDA) approved TlandoTM (testosterone undecanoate oral capsule) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Source: FDA website
New Formulation 03-28-22
Triumeq PD
The Food and Drug Administration (FDA) approved Triumeq PD (abacavir/dolutegravir/lamivudine dispersible tablets for oral suspension) for the treatment of pediatric individuals weighing 10 kg to < 25 kg with human immunodeficiency virus type 1 (HIV-1). The original tablet formulation of Triumeq was also expanded to individuals weighing at least 10 kg. Source: FDA website
New Formulation 03-30-22
Idarubicin
Teva Pharmaceuticals announced a voluntary recall of one lot of idarubicin hydrochloride injection due to the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-idarubicin-hydrochloride-injection-usp-5-mg5-ml-due Source: FDA website
Drug Recall 03-30-22
North American Custom Laboratories
The Food and Drug Administration (FDA) issued a warning not to use products intended to be sterile produced by North American Custom Laboratories due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-sterile-products-north-american-custom?utm_medium=email&utm_source=govdelivery Source: FDA website
Drug Warning 03-31-22
Iodine-containing contrast media
The Food and Drug Administration (FDA) approved a new warning to the prescribing label for the entire class of iodinated contrast media injections and monitoring recommendations for children 3 years or younger. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/iodine-containing-contrast-media-drug-safety-communication-fda-recommends-thyroid-monitoring-babies Source: FDA website
Drug Warning 03-31-22
Yescarta
The Food and Drug Administration (FDA) approved Yescarta® (axicabtagene ciloleucel for intravenous infusion) for adults with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. Source: FDA website
Expanded Indication 04-01-22
Igalmi
The Food and Drug Administration (FDA) approved IgalmiTM (dexmedetomidine sublingual film) for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Source: FDA website
New Formulation 04-05-22
Vijoice
The Food and Drug Administration (FDA) approved Vijoice® (alpelisib tablets) for the treatment of adult and pediatric individuals 2 years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. Source: FDA website
New Formulation 04-05-22
Xigduo XR
The Food and Drug Administration (FDA) approved Xigduo® XR (dapagliflozin/metformin extended-release tablet) to reduce the risk of sustained estimated glomerular filtration rate decline, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. Source: FDA website
Expanded Indication 04-11-22
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
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-m