Drug Information

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

The Food and Drug Administration (FDA) approved Abrysvo® (respiratory syncytial virus vaccine intramuscular injection) to include active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Source: FDA website

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

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

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

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

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

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

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

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

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

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

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

The Food and Drug Administration (FDA) approved Aponvie™ (aprepitant injection) for the prevention of postoperative nausea and vomiting in adults. Source: FDA website

The Food and Drug Administration (FDA) approved Arbli (losartan potassium oral suspension) for the treatment of hypertension in adults and children greater than 6 years old, reduction of the risk of stroke in individuals with hypertension and left ventricular hypertrophy, and treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in individuals with type 2 diabetes and a history of hypertension. Source: FDA website

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

Staska Pharmaceuticals announced a voluntary recall of one lot of ascorbic acid solution for injection due to the presence of glass particulates. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/staska-pharmaceuticals-inc-issues-voluntary-nationwide-recall-ascorbic-acid-solution-injection Source: FDA website

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

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

The Food and Drug Administration (FDA) approved AtzumiTM (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura in adults. Source: FDA website

The Food and Drug Administration (FDA) approved AugtyroTM (repotrectinib capsules) for adult and pediatric individuals 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy. Source: FDA website

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

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

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

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

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

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

The Food and Drug Administration (FDA) approved Bimzelx® (bimekizumab-bkzx injection) for adults with active psoriatic arthritis (PsA), active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS). Source: FDA website

The Food and Drug Administration (FDA) approved Bizengri® (zenocutuzumab-zbco injection) for adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. Source: FDA website

The Food and Drug Administration (FDA) approved Blujepa (gepotidacin tablets) for the treatment of female adult and pediatric individuals 12 years of age and older weighing at least 40 kg with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis. Source: FDA website

The Food and Drug Administration (FDA) approved BoruzuTM (bortezomib ready-to-use subcutaneous injection) for the treatment of adults with multiple myeloma and for the treatment of adults with mantle cell lymphoma. Source: FDA website

The Food and Drug Administration (FDA) approved Braftovi® (encorafenib capsules) with cetuximab and mFOLFOX6 for individuals with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a FDA-approved test. Source: FDA website

The Food and Drug Administration (FDA) approved Brekiya® (dihydroergotamine mesylate autoinjector for subcutaneous use) for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. Source: FDA website

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

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

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

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

The Food and Drug Administration (FDA) approved Brukinsa® (zanubrutinib capsules) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Source: FDA website

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

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

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

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

The Food and Drug Administration (FDA) approved CapvaxiveTM (pneumococcal 21-valent conjugate vaccine injection) for active immunization for the prevention of invasive disease caused by certain Streptococcus pneumoniae and S. pneumoniae serotypes in individuals 18 years of age and older. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Cimzia® (certolizumab pegol injection) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) for individuals 2 years of age and older. Source: FDA website

Endo is expanding a previously announced voluntary recall of clonazepam orally disintegrating tablets due to potential product carton strength mislabeling. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-expands-voluntary-recall-clonazepam-orally-disintegrating-tablets-usp-c-iv-due-potential Source: FDA website

The Food and Drug Administration (FDA) approved CobenfyTM (xanomeline and trospium chloride) for the treatment of schizophrenia in adults. Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved Cotellic® (cobimetinib tablets) for the treatment of adults with histiocytic neoplasms. Source: FDA website

The Food and Drug Administration (FDA) approved CrexontTM (carbidopa/levodapa extended-release capsules) for the treatment of Parkinson’s disease (PD). Source: FDA website

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

The Food and Drug Administration (FDA) approved DanzitenTM (nilotinib tartrate tablets) for the treatment of adults with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Also approved for the treatment of adults with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib. Source: FDA website

The Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj injection) in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in individuals with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). Source: FDA website

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

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

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

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

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

The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for the treatment of adults with prurigo nodularis. Source: FDA website

The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection for subcutanous use) for the treatment of chronic spontaneous urticaria (CSU) in individuals aged 12 years and older who remain symptomatic despite H1 antihistamine treatment. Source: FDA website

The Food and Drug Administration (FDA) approved Dupixent® (dupilumab subcutaneous injection) to include add-on maintenance treatment of adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Source: FDA website

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

The Food and Drug Administration (FDA) approved Elevidys® (delandistrogene moxeparvovec-rokl injection) for expanded use in ambulatory and non-ambulatory individuals 4 years of age and older with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. Source: FDA website

The Food and Drug Administration (FDA) approved Eliquis® (apixaban tablets for oral use and tablets for oral suspension) and Eliquis® Sprinkle (apixaban capsules for oral suspension) for the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric individuals from birth and older after at least 5 days of initial anticoagulant treatment, and for the addition of 0.5 mg tablets for oral suspension. Source: FDA website

The Food and Drug Administration (FDA) approved Emblaveo (aztreonam/avibactam injection for intravenous use) in combination with metronidazole for individuals 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Source: FDA website

The Food and Drug Administration (FDA) approved EmrelisTM (telisotuzumab vedotin-tllv injection for intravenous use) for the treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression, as determined by an FDA-approved test, who have received a prior systemic therapy. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Enhertu® (fam-trastuzumab deruxtecan-nxki injection for intravenous use) for the treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer that has progressed on one or more endocrine therapies in the metastatic setting. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved EpkinlyTM (epcoritamab-bysp injection) for adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Source: FDA website

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

The Food and Drug Administration (FDA) approved Erzofri® (paliperidone palmitate extended-release injectable suspension for intramuscular injection) for the treatment of schizophrenia in adults. Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved Fabhalta® (iptacopan capsules) for the reduction of proteinuria in primary IgA nephropathy (IgAN). Source: FDA website

The Food and Drug Administration (FDA) approved Farxiga® (dapagliflozin tablets) for the treatment of pediatric individuals aged 10 years and above with type-2 diabetes (T2D). Source: FDA website

The Food and Drug Administration (FDA) approved Fasenra® (benralizumab injection) to treat adults with eosinophilic granulomatosis with polyangiitis (EGPA), a type of rare immune-mediated vasculitis. Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved Flumist® (influenza vaccine live intranasal) for self- or caregiver-administration for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. Source: FDA website

The Food and Drug Administration (FDA) is warning consumers and health care providers not to use drugs compounded and distributed by Fullerton Wellness LLC in Ontario, California due to sterility issues. 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-compounded-drugs-fullerton-wellness Source: FDA website

The Food and Drug Administration (FDA) approved expanded use of Furoscix® (furosemide injection for subcutaneous use) to include treatment of congestion due to fluid overload in adults with chronic heart failure (CHF), regardless of New York Heart Association (NYHA) functional class. Source: FDA website

The Food and Drug Administration (FDA) approved Gemtesa® (vibegron tablets) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). Source: FDA website

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

The Food and Drug Administration (FDA) approved Gvoke Vialdx (glucagon injection for intravenous use) for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adults. A new 1 mg/0.2 mL single-dose vial and carton and container labeling for the intravenous use were also approved. Source: FDA website

The Food and Drug Administration (FDA) approved HemiclorTM (chlorthalidone tablets) for the treatment of hypertension in adults. Source: FDA website

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

The Food and Drug Administration (FDA) approved HympavziTM (marstacimab-hncq injection for subcutaneous use) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatrics 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved ImaavyTM (nipocalimab-aahu injection for intravenous use) for the treatment of generalized myasthenia gravis (gMG) in adults and pediatrics 12 years of age and older who are anti-acetylcholine receptor (AChR+) or anti-muscle-specific tyrosine kinase (MuSK+) antibody positive. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Imfinzi® (durvalumab injection for intravenous use) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Source: FDA website

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

The Food and Drug Administration (FDA) approved Imkeldi (imatinib oral solution) to treat chronic myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic/myeloproliferative diseases, and gastrointestinal stromal tumors as well as aggressive systematic mastocytosis, hypereosinophilic syndrome, chronic eosinophilic leukemia, and dermatofibrosarcoma protuberans. Source: FDA website

The Food and Drug Administration (FDA) approved Imfinzi® (durvalumab injection for intravenous use) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC). Source: FDA website

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

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

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

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

The Food and Drug Administration (FDA) approved Isturisa® (osilodrostat tablets) for the treatment of endogenous hypercortisolemia in adults with Cushing syndrome for whom surgery is not an option or has not been curative. Source: FDA website

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are recommending a pause in the use of Ixchiq® (Chikungunya vaccine, live, solution for intramuscular injection) in individuals 60 years of age and older while postmarketing safety reports are investigated. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-and-cdc-recommend-pause-use-ixchiq-chikungunya-vaccine-live-individuals-60-years-age-and-older Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved Jemperli (dostarlimab-gxly injection) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adults with primary advanced or recurrent endometrial cancer (EC). Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved Kevzara® (sarilumab injection) for the treatment of individuals weighing 63 kg or more with active polyarticular juvenile idiopathic arthritis (pJIA). Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Source: FDA website

The Food and Drug Administration (FDA) approved Kisqali® (ribociclib tablets) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. The Food and Drug Administration (FDA) also approved the Kisqali Femara® Co-Pack (ribociclib and letrozole) for the same indication. Source: FDA website

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

The Food and Drug Administration (FDA) approved Krazati® (adagrasib tablets) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved LazcluzeTM (lazertinib tablets) in combination with Rybrevant (amivantamab-vmjw injection) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. Source: FDA website

The Food and Drug Administration (FDA) approved LeqselviTM (deuruxolitinib tablets) for the treatment of adults with severe alopecia areata. Source: FDA website

Dr. Reddy’s Laboratories announced a voluntary recall of one lot of levetiracetam in 0.75% sodium chloride injection due to mislabeling of infusion bag. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-nationwide-recall-levetiracetam-075-sodium-chloride-injection-1000-mg100-ml-us-due Source: FDA website

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

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

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

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

The Food and Drug Administration (FDA) approved Livmarli® (maralixibat oral solution) to include treatment of cholestatic pruritus in individuals 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC). A high concentration formulation was also approved. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved LumryzTM (sodium oxybate extended-release oral suspension) to include treatment of cataplexy or excessive daytime sleepiness (EDS) in adults 7 years of age and older with narcolepsy. Source: FDA website

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

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

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

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

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

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

The Food and Drug Administration (FDA) approved MezofyTM (aripiprazole oral film) for the treatment of schizophrenia. Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved Motpoly XRTM (lacosamide extended-release capsules) for the treatment of primary generalized tonic-clonic seizures in adults and in pediatric individuals weighing at least 50 kg. Source: FDA website

The Food and Drug Administration (FDA) approved Myfembree® (relugolix, estradiol, and norethindrone acetate tablets) for the treatment of endometriosis-associated pain. Source: FDA website

The Food and Drug Administration (FDA) approved Neffy® (epinephrine intranasal spray) for emergency treatment of type I allergic reactions, including anaphylaxis, in individuals who weigh between 15 and 30 kilograms. Source: FDA website

The Food and Drug Administration (FDA) approved Nemluvio® (nemolizumab injection) for the treatment of individuals 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. Source: FDA website

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

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

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

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

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

The Food and Drug Administration (FDA) approved Ocrevus ZunovoTM (ocrelizumab & hyaluronidase-ocsq subcutaneous injection) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Source: FDA

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

The Food and Drug Administration (FDA) approved Odefsey® (emtricitabine/rilpivirine/tenofovir alafenamide tablets) label expansion to include pediatric individuals weighing at least 25 kg to less than 35 kg for the treatment of human immunodeficiency virus-1 (HIV-1) infection as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL and pediatric individuals weighing at least 25 to less than 35 kg for the treatment of HIV-1 infection to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL). Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved OnapgoTM (apomorphine hydrochloride subcutaneous infusion device) for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. Sourc: FDA website

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

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

The Food and Drug Administration (FDA) approved Opdivo® (nivomulab injection for intravenous use) with Yervoy® (ipilimumab injection for intravenous use) for adult and pediatric individuals 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). Source: FDA website

The Food and Drug Administration (FDA) approved Opdivo QvantigTM (nivolumab and hyaluronidase-nvhy subcutaneous injection) for renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal carcinoma, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved OrlynvahTM (sulopenem etzadroxil and probenecid tablets) for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. Source: FDA website

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

The Food and Drug Administration (FDA) approved Ozempic® (semaglutide injection for subcutaneous use) to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Penmenvy (meningococcal groups A, B, C, W, and Y vaccine injection for intramuscular use) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age. Source: FDA website

Central Admixture Pharmacy announced the voluntary recall of three lots of phenylephrine 40 mg added to 0.9% sodium chloride 250 mL due to visible black particular matter in a single-sealed vial. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/central-admixture-pharmacy-services-caps-issues-nationwide-recall-phenylephrine-40-mg-added-09 Source: FDA website

The Food and Drug Administration (FDA) approved PiaSky (crovalimab-akkz injection) for the treatment of adults and pediatrics 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg. Source: FDA website

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

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

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

Glenmark Pharmaceuticals announced a voluntary recall of 114 batches of potassium chloride extended-release capsules 750 mg due to failed dissolution. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/glenmark-pharmaceuticals-inc-usa-issues-voluntary-nationwide-recall-potassium-chloride-extended Source: FDA website

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

The Food and Drug Administration (FDA) approved Prevymis® (letermovir tablets, injection, and oral pellets) to expand use to include pediatric hematopoietic stem cell transplant recipients 6 months of age and older and weighing at least 6 kg and pediatric kidney transplant recipients 12 years of age and older and weighing at least 40 kg. An oral pellet formulation was also approved. Source: FDA website

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

The Food and Drug Administration (FDA) approved Protonix® I.V. (pantoprazole sodium injection for intravenous use) for the treatment of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 7 days in pediatric individuals 3 months and older.

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

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

The Food and Drug Administration (FDA) approved QlosiTM (pilocarpine 0.4% ophthalmic solution) for the treatment of presbyopia in adults. Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved Rapiblyk (landiolol injection) for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter. Source: FDA website

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

The Food and Drug Administration (FDA) has approved labeling changes for AbrysvoTM (respiratory syncytial virus vaccine intramuscular injection) and Arexvy (respiratory syncytial virus vaccine, adjuvanted intramuscular injection) to include a warning about the risk for Guillain-Barré syndrome (GBS). Contact your healthcare provider. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and Source: FDA website

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

The Food and Drug Administration (FDA) approved Revuforj® (revumenib tablets) for relapsed or refractory acute leukemia lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric individuals aged 1 year and older. Source: FDA website

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

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

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

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

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

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

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

Amneal Pharmaceuticals announced a voluntary recall of two lots of ropivacaine hydrochloride injection 500 mg/100 mL infusion bags due to the potential 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/amneal-pharmaceutical-llc-issues-nationwide-recall-ropivacaine-hydrochloride-injection-usp Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved Rytelo (imetelstat injection) for the treatment of adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell (RBC) units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). Source: FDA website

The Food and Drug Administration (FDA) approved Sarclisa® (isatuximab-irfc injection) for use with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). Source: FDA website

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

The Food and Drug Administration (FDA) approved SezabyTM (phenobarbital injection) for the treatment of neonatal seizures. Source: FDA website

The Food and Drug Administration (FDA) approved SkyriziTM (risankizumab-rzaa injection) for the treatment of adults with active psoriatic arthritis (PsA). Source: FDA website

The Food and Drug Administration (FDA) approved Skyrizi® (risankizumab-rzaa injection) for the treatment of moderately-to-severely active ulcerative colitis in adults. Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved SofdraTM (sofpironium topical gel) for the treatment of primary axillary hyperhidrosis in adults and pediatric individuals 9 years of age and older. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Spevigo® (spesolimab-sbzo injection) for the treatment of generalized pustular psoriasis flares in adults. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved SusvimoTM (ranibizumab injection for ocular implant) for the treatment of diabetic macular edema (DME). Source: FDA website

The Food and Drug Administration (FDA) approved Symbravo (meloxicam/rizatriptan oral tablets) for acute migraine treatment with or without aura. Source: FDA website

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

The Food and Drug Administration (FDA) approved Syndardy® (empagliflozin/metformin hydrochloride) and Syndardy® XR (empagliflozin/metformin hydrochloride extended-release tablets) in adults with type 2 diabetes mellitus 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 at risk of progression. Source: FDA website

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

The Food and Drug Administration (FDA) approved Tagrisso® (osimertinib tablets) for adults with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by a Food and Drug Administration (FDA)-approved test. Source: FDA website

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

The Food and Drug Administration (FDA) approved Tecelra® (afamitresgene autoleucel suspension for intravenous infusion) for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are Human Leukocyte Antigen (HLA)-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the melanoma-associated antigen A4 (MAGE-A4) as determined by FDA-approved or cleared companion diagnostic devices. Source: FDA website

The Food and Drug Administration (FDA) approved Tecentriq HybrezaTM (atezolizumab and hyaluronidase-tqjs subcutaneous injection) for all the adult indications as the intravenous formulation including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS). Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Tevimbra® (tislelizumab-jsgr injection) for use in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express programmed death-ligand 1 (PD-L1) ≥1. Source: FDA website

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

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

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

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

The Food and Drug Administration (FDA) approved Tremfya® (guselkumab injection) to treat moderate-to-severe active ulcerative colitis (UC) in adults. Source: FDA website

The Food and Drug Administration (FDA) approved Trikafta® (elexacaftor/tezacaftor/ivacaftor tablets and oral granules) for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive to Trikafta based on clinical and/or in vitro data. With this approval, 94 additional non-F508del CFTR mutations have been added to the Trikafta label. Source: FDA website

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

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

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

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

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

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

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

The Food and Drug Administration (FDA) approved Uplizna® (inebilizumab-cdon injection for intravenous use) for the treatment of immunoglobulin G4-related disease (IgG4-RD) in adults. Source: FDA website

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

The Food and Drug Administration (FDA) approved VabysmoTM (faricimab-svoa 6.0 mg single-dose prefilled syringe for intravitreal injection) for use in the treatment of neovascular or wet age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Source: FDA website

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

The Food and Drug Administration (FDA) approved VanrafiaTM (atrasentan tablets) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. Source: FDA website

Gilead Sciences announced a voluntary recall of one lot of Veklury® (remdesivir) for injection 100 mg/vial due to the presence of a glass particle. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gilead-issues-voluntary-nationwide-recall-one-lot-veklury-remdesivir-injection-100-mgvial-due Source: FDA website

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

The Food and Drug Administration (FDA) approved Velphoro® (ferric oxyhydroxide chewable tables) for the control of serum phosphorus levels in adult and pediatric individuals 9 years of age and older with chronic kidney disease on dialysis. Source: FDA website

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

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

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

The Food and Drug Admistration (FDA) added a Boxed Warning to the Veozah labeling to highlight the risk of rare but serious liver injury associated with use. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due Source: FDA website

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

The Food and Drug Administration (FDA) approved VigafydeTM (vigabatrin oral solution) as monotherapy for the treatment of pediatric individuals 1 month to 2 years of age with infantile spasms for whom the potential benefits outweigh the potential risk of vision loss. Source: FDA website

The Food and Drug Administration (FDA) approved VimkunyaTM (chikungunya vaccine, recombinant injection for intramuscular use) for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older. Source: FDA website

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

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

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

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

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

The Food and Drug Administration (FDA) approved Vtama® (tapinarof topical cream) for the treatment of atopic dermatitis (AD) in adults and pediatric individuals 2 years of age and older. Source: FDA website

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

The Food and Drug Administration (FDA) approved VyloyTM (zolbetuximab-clzb injection for intravenous use) in combination 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 adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. Source: FDA website

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

The Food and Drug Administration (FDA) approved Wakix® (pitolisant tablets) for the treatment of excessive daytime sleepiness (EDS) in pediatric individuals 6 years of age and older with narcolepsy. Source: FDA website

The Food and Drug Administration (FDA) approved Welireg® (belzutifan tablets) for adult and pediatric individuals 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). Source: FDA website

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

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

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

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

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

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

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

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

The Food and Drug Administration (FDA) approved Yorvipath® (palopegteriparatide injection for subcutaneous use) for the treatment of hypoparathyroidism in adults. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Ziihera® (zanidatamab-hrii injection) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer. Source: FDA website

The Food and Drug Administration (FDA) approved Zituvimet XR (sitagliptin/metformin hydrochloride extended-release tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved Zunveyl® (benzgalantamine delayed release tablets) for the treatment of mild-to-moderate dementia in adults. Source: FDA website

The Food and Drug Administration (FDA) approved ZurzuvaeTM (zuranolone capsules) for the treatment of postpartum depression (PPD) in adults. Source: FDA website

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

The Food and Drug Administration (FDA) approved Zynyz® (retifanlimab-dlwr injection for intravenous use) with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). It was also approved as a single agent for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. Source: FDA website