FDA approvals, September 2026

The FDA approved 16 new drug or biologic applications and 16 efficacy supplements (new uses for approved drugs) in September 2026, per Drugs@FDA as read on 2026-11-12.

New drug and biologic applications · 16

• Sep 3: the FDA approved Omcazio (cabozantinib laurylsulfate), Handa Oncol, NDA220613 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
• Sep 3: the FDA approved Zanvastro (zilganersen), Ionis Pharms Inc, NDA220210 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Sep 4: the FDA approved Etcamah (camizestrant), Astrazeneca, NDA220359 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Sep 11: the FDA approved Isembyld (apitegromab-mstn), Scholar Rock Inc, BLA761463 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Sep 11: the FDA approved Pixclara (floretyrosine f18), Telix, NDA218592 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Sep 14: the FDA approved Bexlutry (lutetium lu 177 dotatate), Curium, NDA218525 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
• Sep 15: the FDA approved Garzulys (insulin aspart-fsan), Emerge Bioscience Pte. Ltd., BLA761497 ORIG-2. FDA letter.
• Sep 22: the FDA approved Carbon Dioxide, Usp, Agl Welding Supply Co Inc Dba Agl Gas Technologies, NDA222000 ORIG-1. FDA letter.
• Sep 23: the FDA approved Lyrfigtu (lirafugratinib hydrochloride), Elevar, NDA220425 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Sep 23: the FDA approved Onswik Kwikpen (insulin efsitora alfa-gobe), Eli Lilly And Co, BLA761408 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Sep 25: the FDA approved Atebrioz (zilurgisertib), Mirum, NDA221198 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Sep 25: the FDA approved Degevma (denosumab-adet), Teva Pharmaceuticals, Inc., BLA761481 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
• Sep 25: the FDA approved Juvmo (tavapadon), Abbvie, NDA220415 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
• Sep 25: the FDA approved Lamlique (lamotrigine hemifumarate), Azurity, NDA221109 ORIG-1 (Type 2 - New Active Ingredient). FDA letter.
• Sep 25: the FDA approved Zueino (diclofenac sodium), Adventapharma, NDA218379 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
• Sep 28: the FDA approved Emcitate (tiratricol), Rare Thyroid, NDA220963 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.

New uses for approved drugs (efficacy supplements) · 16

• Sep 9: the FDA approved an efficacy supplement for Ameluz (aminolevulinic acid hydrochloride), Biofrontera, NDA208081 SUPPL-40. FDA letter.
• Sep 9: the FDA approved an efficacy supplement for Hyrnuo (sevabertinib), Bayer Healthcare, NDA219972 SUPPL-1. FDA letter.
• Sep 11: the FDA approved an efficacy supplement for Joenja (leniolisib), Pharming, NDA217759 SUPPL-6. FDA letter.
• Sep 14: the FDA approved an efficacy supplement for Tagrisso (osimertinib), Astrazeneca, NDA208065 SUPPL-35. FDA letter.
• Sep 16: the FDA approved an efficacy supplement for Ibtrozi (taletrectinib), Nuvation, NDA219713 SUPPL-4. FDA letter.
• Sep 16: the FDA approved an efficacy supplement for Kerendia (finerenone), Bayer Hlthcare, NDA215341 SUPPL-11. FDA letter.
• Sep 16: the FDA approved an efficacy supplement for Truqap (capivasertib), Astrazeneca, NDA218197 SUPPL-6. FDA letter.
• Sep 18: the FDA approved an efficacy supplement for Aqneursa (levacetylleucine), Intrabio, NDA219132 SUPPL-2. FDA letter.
• Sep 18: the FDA approved an efficacy supplement for Inluriyo (imlunestrant), Eli Lilly And Co, NDA218881 SUPPL-1. FDA letter.
• Sep 18: the FDA approved an efficacy supplement for Verzenio (abemaciclib), Eli Lilly And Co, NDA208716 SUPPL-22. FDA letter.
• Sep 21: the FDA approved an efficacy supplement for Winrevair (sotatercept-csrk), Merck Sharp Dohme, BLA761363 SUPPL-12. FDA letter.
• Sep 24: the FDA approved an efficacy supplement for Lenvima (lenvatinib), Eisai Inc, NDA206947 SUPPL-35. FDA letter.
• Sep 24: the FDA approved an efficacy supplement for Welireg (belzutifan), Merck Sharp Dohme, NDA215383 SUPPL-13. FDA letter.
• Sep 25: the FDA approved an efficacy supplement for Gazyva (obinutuzumab), Genentech, BLA125486 SUPPL-43. FDA letter.
• Sep 25: the FDA approved an efficacy supplement for Olumiant (baricitinib), Eli Lilly And Co, NDA207924 SUPPL-9. FDA letter.
• Sep 30: the FDA approved an efficacy supplement for Camzyos (mavacamten), Bristol, NDA214998 SUPPL-13. 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. ← August 2026 · October 2026 → · all months · PDUFA decisions this month · decisions we tracked in 2026