Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved 16 new drug or biologic applications and 11 efficacy supplements (new uses for approved drugs) in August 2025, per Drugs@FDA as read on 2026-11-12.
New drug and biologic applications · 16
Aug 1: the FDA approved E-Z-Disk (barium sulfate), Bracco, NDA219840 ORIG-1 (Type 7 - Drug Already Marketed without Approved NDA). FDA letter.
Aug 6: the FDA approved Modeyso (dordaviprone), Chimerix, NDA219876 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Aug 8: the FDA approved Hernexeos (zongertinib), Boehringer Ingelheim, NDA219042 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Aug 8: the FDA approved Kyxata (carboplatin), Avyxa Holdings, NDA219921 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Aug 12: the FDA approved Brinsupri (brensocatib), Insmed Inc, NDA217673 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Aug 15: the FDA approved Cyklx (articaine hydrochloride), Thea Pharma, NDA218643 ORIG-1 (Type 3 - New Dosage Form and Type 4 - New Combination). FDA letter.
Aug 15: the FDA approved Tonmya (cyclobenzaprine hydrochloride), Tonix, NDA219428 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Aug 21: the FDA approved Dawnzera (donidalorsen), Ionis Pharms Inc, NDA219407 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
Aug 25: the FDA approved Camcevi Etm (leuprolide), Accord, NDA219745 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Aug 28: the FDA approved Lopressor (metoprolol tartrate), Xtm Consulting, NDA218698 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Aug 29: the FDA approved Bilprevda (denosumab), Shanghai Henlius Biotech, BLA761444 ORIG-1. FDA letter.
Aug 29: the FDA approved Escitalopram, Almatica, NDA219130 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Aug 29: the FDA approved Lecanemab Autoinjector (lecanemab-irmb), Eisai Inc, BLA761375 ORIG-1 (Type 3 - New Dosage Form). FDA letter.
Aug 29: the FDA approved Otezla (apremilast), Amgen Inc, NDA210745 ORIG-2 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Aug 29: the FDA approved Otezla (apremilast), Amgen Inc, NDA210745 ORIG-1 (Type 5 - New Formulation or New Manufacturer). FDA letter.
Aug 29: the FDA approved Wayrilz (rilzabrutinib), Genzyme Corp, NDA219685 ORIG-1 (Type 1 - New Molecular Entity). FDA letter.
New uses for approved drugs (efficacy supplements) · 11
Aug 1: the FDA approved an efficacy supplement for Phyrago (dasatinib), Handa Therap, NDA216099 SUPPL-5. FDA letter.
Aug 5: the FDA approved an efficacy supplement for Ajovy (fremanezumab-vfrm), Teva Pharms Usa, BLA761089 SUPPL-31. FDA letter.
Aug 8: the FDA approved an efficacy supplement for Actemra (tocilizumab), Genentech, BLA125276 SUPPL-149. FDA letter.
Aug 14: the FDA approved an efficacy supplement for Lazcluze (lazertinib), Janssen Biotech, NDA219008 SUPPL-2. FDA letter.
Aug 14: the FDA approved an efficacy supplement for Rybrevant (amivantamab-vmjw), Janssen Biotech, BLA761210 SUPPL-9. FDA letter.
Aug 15: the FDA approved an efficacy supplement for Wegovy (semaglutide), Novo, NDA215256 SUPPL-24. FDA letter.
Aug 18: the FDA approved an efficacy supplement for Vyepti (eptinezumab-jjmr), Lundbeck Seattle Biopharmaceuticals, Inc., BLA761119 SUPPL-10.
Aug 25: the FDA approved an efficacy supplement for Kloxxado (naloxone hcl), Hikma, NDA212045 SUPPL-5. FDA letter.
Aug 27: the FDA approved an efficacy supplement for Filspari (sparsentan), Travere, NDA216403 SUPPL-5. FDA letter.
Aug 27: the FDA approved an efficacy supplement for Ojemda (tovorafenib), Day One Biopharms, NDA217700 SUPPL-2. FDA letter.
Aug 27: the FDA approved an efficacy supplement for Ojemda (tovorafenib), Day One Biopharms, NDA218033 SUPPL-2. FDA letter.