Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved 17 new drug or biologic applications and 33 efficacy supplements (new uses for approved drugs) in April 2025, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 17
Apr 2: the FDA approved Vanrafia (atrasentan), Novartis, NDA219208 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Apr 3: the FDA approved Piperacillin And Tazobactam And Sodium Chloride, B Braun Medical, NDA206056 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Apr 9: the FDA approved Jobevne (bevacizumab-nwgd), Biocon Biologics Inc, BLA761175 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Apr 10: the FDA approved Livmarli (maralixibat chloride), Mirum, NDA219485 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Apr 10: the FDA approved Lopressor (metoprolol tartrate), Rubicon Research, NDA219373 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Apr 15: the FDA approved Mezofy (aripiprazole), Cmg Pharm Co Ltd, NDA211448 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Apr 17: the FDA approved Eliquis (apixaban), Bristol, NDA220073 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Apr 21: the FDA approved Carbon Dioxide, Mitchell Wedling Supply, NDA220461 ORIG-1. FDA letter.
Apr 22: the FDA approved Qamzova (meloxicam), Nanjing Delova, NDA217593 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Apr 23: the FDA approved Penpulimab Kcqx (penpulimab), Akeso Biopharma, BLA761258 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Apr 29: the FDA approved Imaavy (nipocalimab-aahu), Janssen Biotech, BLA761430 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Apr 30: the FDA approved Atzumi (dihydroergotamine mesylate), Satsuma Pharms, NDA217901 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Apr 30: the FDA approved Otulfi (ustekinumab-aauz), Fresenius Kabi Usa, BLA761379 ORIG-2 (Efficacy). FDA letter.
Apr 30: the FDA approved Steqeyma (ustekinumab-stba), Celltrion, Inc., BLA761338 ORIG-2 (Type 2 - New Active Ingredient). FDA letter.
Apr 30: the FDA approved Ustekinumab-Ttwe, Samsung Bioepis Co Ltd, BLA761425 ORIG-2 (Type 3 - New Dosage Form). FDA letter.
Apr 30: the FDA approved Ustekinumab-Ttwe, Samsung Bioepis Co Ltd, BLA761373 ORIG-2 (Type 2 - New Active Ingredient). FDA letter.
Apr 30: the FDA approved Yesintek (ustekinumab-kfce), Biocon Biologics Inc, BLA761406 ORIG-2. FDA letter.
New uses for approved drugs (efficacy supplements) · 33
Apr 3: the FDA approved an efficacy supplement for Uplizna (inebilizumab), Viela Bio, BLA761142 SUPPL-3. FDA letter.
Apr 4: the FDA approved an efficacy supplement for Sivextro (tedizolid phosphate), Cubist Pharms Llc, NDA205436 SUPPL-13. FDA letter.
Apr 4: the FDA approved an efficacy supplement for Sivextro (tedizolid phosphate), Cubist Pharms Llc, NDA205435 SUPPL-16. FDA letter.
Apr 7: the FDA approved an efficacy supplement for Amjevita (adalimumab-atto), Amgen Inc, BLA761024 SUPPL-23. FDA letter.
Apr 7: the FDA approved an efficacy supplement for Cyramza (ramucirumab), Eli Lilly And Co, BLA125477 SUPPL-49. FDA letter.
Apr 7: the FDA approved an efficacy supplement for Dextenza (dexamethasone), Ocular Therapeutix, NDA208742 SUPPL-13. FDA letter.
Apr 8: the FDA approved an efficacy supplement for Opdivo (nivolumab), Bristol Myers Squibb, BLA125554 SUPPL-132. FDA letter.
Apr 8: the FDA approved an efficacy supplement for Yervoy (ipilimumab), Bristol Myers Squibb, BLA125377 SUPPL-135. FDA letter.
Apr 9: the FDA approved an efficacy supplement for Vitrakvi (larotrectinib), Bayer Hlthcare, NDA210861 SUPPL-12. FDA letter.
Apr 9: the FDA approved an efficacy supplement for Vitrakvi (larotrectinib), Bayer Healthcare, NDA211710 SUPPL-10. FDA letter.
Apr 10: the FDA approved an efficacy supplement for Darzalex (daratumumab), Janssen Biotech, BLA761036 SUPPL-54. FDA letter.
Apr 10: the FDA approved an efficacy supplement for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase (human recombinant)), Argenx Bv, BLA761304 SUPPL-8. FDA letter.
Apr 11: the FDA approved an efficacy supplement for Opdivo (nivolumab), Bristol Myers Squibb, BLA125554 SUPPL-129. FDA letter.
Apr 11: the FDA approved an efficacy supplement for Yervoy (ipilimumab), Bristol Myers Squibb, BLA125377 SUPPL-133. FDA letter.
Apr 15: the FDA approved an efficacy supplement for Isturisa (osilodrostat), Recordati Rare, NDA212801 SUPPL-3. FDA letter.
Apr 15: the FDA approved an efficacy supplement for Valtoco (diazepam), Neurelis Inc, NDA211635 SUPPL-10. FDA letter.
Apr 15: the FDA approved an efficacy supplement for Welireg (belzutifan), Merck Sharp Dohme, NDA215383 SUPPL-10. FDA letter.
Apr 15: the FDA approved an efficacy supplement for Welireg (belzutifan), Merck Sharp Dohme, NDA215383 SUPPL-11. FDA letter.
Apr 16: the FDA approved an efficacy supplement for Posfrea (palonosetron), Avyxa Holdings, NDA203050 SUPPL-3. FDA letter.
Apr 17: the FDA approved an efficacy supplement for Camzyos (mavacamten), Bristol, NDA214998 SUPPL-10. FDA letter.
Apr 17: the FDA approved an efficacy supplement for Dupixent (dupilumab), Regeneron Pharmaceuticals, BLA761055 SUPPL-51. FDA letter.
Apr 17: the FDA approved an efficacy supplement for Eliquis (apixaban), Bristol Myers Squibb, NDA202155 SUPPL-39. FDA letter.
Apr 17: the FDA approved an efficacy supplement for Eliquis (apixaban), Bristol Myers Squibb, NDA202155 SUPPL-40. FDA letter.
Apr 21: the FDA approved an efficacy supplement for Keytruda (pembrolizumab), Merck Sharp Dohme, BLA125514 SUPPL-174. FDA letter.
Apr 22: the FDA approved an efficacy supplement for Tevimbra (tislelizumab-jsgr), Beigene, BLA761232 SUPPL-2. FDA letter.
Apr 22: the FDA approved an efficacy supplement for Tevimbra (tislelizumab-jsgr), Beigene, BLA761232 SUPPL-12. FDA letter.
Apr 22: the FDA approved an efficacy supplement for Tevimbra (tislelizumab-jsgr), Beigene, BLA761232 SUPPL-5. FDA letter.
Apr 22: the FDA approved an efficacy supplement for Tevimbra (tislelizumab-jsgr), Beigene, BLA761232 SUPPL-3. FDA letter.
Apr 22: the FDA approved an efficacy supplement for Tevimbra (tislelizumab-jsgr), Beigene, BLA761232 SUPPL-11. FDA letter.
Apr 22: the FDA approved an efficacy supplement for Tevimbra (tislelizumab-jsgr), Beigene, BLA761232 SUPPL-6. FDA letter.
Apr 23: the FDA approved an efficacy supplement for Ibrance (palbociclib), Pfizer, NDA212436 SUPPL-8. FDA letter.
Apr 23: the FDA approved an efficacy supplement for Ibrance (palbociclib), Pfizer, NDA207103 SUPPL-20. FDA letter.
Apr 28: the FDA approved an efficacy supplement for Rinvoq (upadacitinib), Abbvie, NDA211675 SUPPL-25. 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. ← March 2025 · May 2025 → · all months · PDUFA decisions this month · decisions we tracked in 2025