FDA approvals, March 2025

The FDA approved 11 new drug or biologic applications and 24 efficacy supplements (new uses for approved drugs) in March 2025, per Drugs@FDA as read on 2026-11-12.

New drug and biologic applications · 11

• Mar 3: the FDA approved Tevimbra (islelizumab-jsgr), Beigene, BLA761380 ORIG-1 (Type 9 - New indication submitted as distinct BLA, consolidated). FDA letter.
• Mar 7: the FDA approved Omlyclo (omalizumab-igec), Celltrion Inc, BLA761399 ORIG-1. FDA letter.
• Mar 13: the FDA approved Arbli (losartan potassium), Scienture, NDA218772 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
• Mar 13: the FDA approved Epinephrine, Fresenius Kabi Usa, NDA215425 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
• Mar 14: the FDA approved Tyenne (tocilizumab-aazg), Fresenius Kabi Usa, BLA761449 ORIG-1. FDA letter.
• Mar 17: the FDA approved Hemiclor (chlorthalidone), Prm Pharma, NDA218647 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
• Mar 20: the FDA approved Gozellix (gozetotide), Telix Innovations, NDA219592 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
• Mar 25: the FDA approved Blujepa (gepotidacin), Glaxosmithkline, NDA218230 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Mar 25: the FDA approved Conexxence (denosumab), Fresenius Kabi Usa Llc, BLA761398 ORIG-1. FDA letter.
• Mar 26: the FDA approved Vykat Xr (diazoxide choline), Soleno, NDA216665 ORIG-1 (Type 2 - New Active Ingredient). FDA letter.
• Mar 28: the FDA approved Qfitlia (fitusiran), Genzyme Corp, NDA219019 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.

New uses for approved drugs (efficacy supplements) · 24

• Mar 5: the FDA approved an efficacy supplement for Neffy (epinephrine), Ars Pharms Operation, NDA214697 SUPPL-1. FDA letter.
• Mar 6: the FDA approved an efficacy supplement for Furoscix (furosemide injection 80 mg/ 10 ml), Scpharmaceuticals, NDA209988 SUPPL-3. FDA letter.
• Mar 7: the FDA approved an efficacy supplement for Mekinist (trametinib), Novartis, NDA204114 SUPPL-34. FDA letter.
• Mar 7: the FDA approved an efficacy supplement for Mekinist (trametinib), Novartis, NDA217513 SUPPL-5. FDA letter.
• Mar 7: the FDA approved an efficacy supplement for Synjardy (empagliflozin and metformin hydrochloride), Boehringer Ingelheim, NDA206111 SUPPL-45. FDA letter.
• Mar 7: the FDA approved an efficacy supplement for Synjardy Xr (empagliflozin, metformin hydrochloride), Boehringer Ingelheim, NDA208658 SUPPL-32. FDA letter.
• Mar 7: the FDA approved an efficacy supplement for Tafinlar (dabrafenib), Novartis, NDA217514 SUPPL-6. FDA letter.
• Mar 7: the FDA approved an efficacy supplement for Tafinlar (dabrafenib), Novartis, NDA202806 SUPPL-33. FDA letter.
• Mar 12: the FDA approved an efficacy supplement for Braftovi (encorafenib), Array Biopharma Inc, NDA210496 SUPPL-18. FDA letter.
• Mar 12: the FDA approved an efficacy supplement for Mektovi (binimetinib), Array Biopharma Inc, NDA210498 SUPPL-11. FDA letter.
• Mar 13: the FDA approved an efficacy supplement for Sohonos (palovarotene), Ipsen, NDA215559 SUPPL-2. FDA letter.
• Mar 14: the FDA approved an efficacy supplement for Gvoke Hypopen 0.5 Mg Auto-Injector (glucagon injection, solution), Xeris, NDA212097 SUPPL-12. FDA letter.
• Mar 17: the FDA approved an efficacy supplement for Baqsimi (glucagon), Amphastar Pharms Inc, NDA210134 SUPPL-4. FDA letter.
• Mar 19: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-170. FDA letter.
• Mar 20: the FDA approved an efficacy supplement for Amvuttra (vutrisiran), Alnylam Pharms Inc, NDA215515 SUPPL-6. FDA letter.
• Mar 20: the FDA approved an efficacy supplement for Fabhalta (iptacopan), Novartis, NDA218276 SUPPL-4. FDA letter.
• Mar 20: the FDA approved an efficacy supplement for Tremfya (guselkumab), Janssen Biotech, BLA761061 SUPPL-24. FDA letter.
• Mar 21: the FDA approved an efficacy supplement for Prezcobix (darunavir ethanolate and cobicistat), Janssen Prods, NDA205395 SUPPL-28. FDA letter.
• Mar 26: the FDA approved an efficacy supplement for Cabometyx (cabozantinib), Exelixis Inc, NDA208692 SUPPL-17. FDA letter.
• Mar 27: the FDA approved an efficacy supplement for Rivfloza (nedosiran), Novo, NDA215842 SUPPL-2. FDA letter.
• Mar 28: the FDA approved an efficacy supplement for Abilify Asimtufii (aripiprazole), Otsuka, NDA217006 SUPPL-1. FDA letter.
• Mar 28: the FDA approved an efficacy supplement for Abilify Maintena (aripiprazole), Otsuka Pharm Co Ltd, NDA202971 SUPPL-18. FDA letter.
• Mar 28: the FDA approved an efficacy supplement for Imfinzi (durvalumab), Astrazeneca Uk Ltd, BLA761069 SUPPL-50. FDA letter.
• Mar 28: the FDA approved an efficacy supplement for Pluvicto (lutetium lu 177 vipivotide tetraxetan), Novartis, NDA215833 SUPPL-21. FDA letter.

Source: openFDA drugsfda (the Drugs@FDA data), read 2026-11-12. openFDA trails Drugs@FDA by about a week, so the latest days of a month can be missing until the next read. Generic approvals (ANDAs), labeling-only and manufacturing supplements are not listed. ← February 2025 · April 2025 → · all months · PDUFA decisions this month · decisions we tracked in 2025