FDA Drug Approvals - 2026-09-13
FDA drug approvals recorded by openFDA between 2026-08-30 and 2026-09-13, newest first. Company is the first listed manufacturer; tickers link to Seeking Alpha. Approval Date Company Drug Ticker 2026-09-09 Bayer HealthCare Pharmaceuticals Inc. HYRNUO BAYRY 2026-09-09 Biofrontera Inc. AMELUZ n/a 2026-09-08 HETERO LABS LTD V IBRUTINIB n/a 2026-09-08 Saptalis Pharmaceuticals, LLC. TRIAMCINOLONE ACETONIDE n/a 2026-09-08 ZHEJIANG JUTAI PHARM BRIVARACETAM n/a 2026-09-04 ACTAVIS ELIZABETH DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE n/a 2026-09-04 AstraZeneca Pharmaceuticals LP ETCAMAH AZN 2026-09-04 Clarity Cosmetics Inc. MINOXIDIL n/a 2026-09-04 MICRO LABS TOPIRAMATE AMD 2026-09-04 NorthStar Rx LLC NITROFURANTOIN n/a 2026-09-04 Tris Pharma Inc LACOSAMIDE n/a 2026-09-03 BPI LABS TESTOSTERONE CYPIONATE n/a 2026-09-03 HANDA ONCOLOGY, LLC n/a n/a 2026-09-03 Horizon Therapeutics USA, Inc. UPLIZNA AMGN 2026-09-03 IONIS PHARMS INC ZANVASTRO IONS 2026-09-03 LUPIN MODAFINIL n/a 2026-09-03 Modavar Pharmaceuticals LLC ACYCLOVIR n/a 2026-09-03 Novadoz Pharmaceuticals LLC TAPENTADOL HYDROCHLORIDE n/a 2026-09-02 Aadi Bioscience, Inc. FYARRO n/a 2026-09-02 Actavis Pharma, Inc. BUPROPION HYDROCHLORIDE SR n/a 2026-09-02 Ajanta Pharma USA Inc. DAPAGLIFLOZIN n/a 2026-09-02 AUROBINDO PHARMA LTD SACUBITRIL AND VALSARTAN n/a 2026-09-02 Celgene Corporation THALOMID n/a 2026-09-02 CELLTRION USA, Inc. AVTOZMA n/a 2026-09-02 H2-Pharma, LLC ETOPOPHOS n/a 2026-09-02 NATCO THALIDOMIDE n/a 2026-09-02 PHARMOBEDIENT DIVALPROEX SODIUM n/a 2026-09-02 PRECISION DOSE INC ALENDRONATE SODIUM n/a 2026-09-02 SUN PHARM INDS LTD OXCARBAZEPINE n/a 2026-09-02 U.S. Pharmaceuticals CIBINQO n/a 2026-09-01 B. Braun Medical Inc. LIDOCAINE HCL AND EPINEPHRINE n/a 2026-09-01 BIOGEN INC. BYOOVIZ BIIB 2026-09-01 Chartwell RX, LLC ULTRAMICROSIZE GRISEOFULVIN n/a 2026-09-01 Leading Pharma, LLC DOXEPIN HYDROCHLORIDE n/a 2026-09-01 Meitheal Pharmaceuticals Inc NELARABINE n/a 2026-09-01 Mirati Therapeutics, Inc KRAZATI BMY 2026-09-01 Mylan Pharmaceuticals Inc. NEVIRAPINE VTRS 2026-09-01 Pharmacia & Upjohn Company LLC CLEOCIN HYDROCHLORIDE VTRS 2026-08-31 Akeso Biopharma, Co., Ltd PENPULIMAB KCQX n/a 2026-08-31 AstraZeneca Pharmaceuticals LP IMFINZI AZN 2026-08-31 AstraZeneca Pharmaceuticals LP IMJUDO AZN 2026-08-31 Aurohealth LLC FEXOFENADINE HYDROCHLORIDE n/a 2026-08-31 Baxter Healthcare Corporation CEFAZOLIN BAX 2026-08-31 Baxter Healthcare Corporation OXACILLIN BAX 2026-08-31 Chattem, Inc. CHILDRENS XYZAL ALLERGY n/a 2026-08-31 Cipla USA Inc. POMALIDOMIDE n/a 2026-08-31 Coherus Oncology, Inc. LOQTORZI CHRS 2026-08-31 Dr. Reddy’s Laboratories Inc. POMALIDOMIDE RDY 2026-08-31 E.R. Squibb & Sons, L.L.C. YERVOY BMY 2026-08-31 EMD Serono, Inc. BAVENCIO MKKGY 2026-08-31 Leading Pharma, LLC FENOFIBRIC ACID n/a 2026-08-31 Lupin Pharmaceuticals, Inc. MEFENAMIC ACID n/a 2026-08-31 MACLEODS PHARMS LTD SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE n/a 2026-08-31 Micro Labs Limited MEFENAMIC ACID AMD 2026-08-31 Micro Labs Limited TRANEXAMIC ACID AMD 2026-08-31 PETNET Solutions, Inc. FLUDEOXYGLUCOSE F 18 n/a 2026-08-31 QILU PHARM HAINAN DIFELIKEFALIN ACETATE n/a 2026-08-31 Regeneron Pharmaceuticals, Inc. LIBTAYO REGN 2026-08-31 SANDOZ EPLERENONE SDZWF 2026-08-31 SANDOZ TERIFLUNOMIDE SDZWF 2026-08-31 Sandoz Inc POMALIDOMIDE SDZWF 2026-08-31 Sun Pharmaceutical Industries, Inc. POMALIDOMIDE n/a 2026-08-31 Sun Pharmaceutical Industries, Inc. UNLOXCYT n/a Only the 63 most relevant rows are shown. Approved applications (originals and supplements) in this window: 64; rows shown: 63; tickers identified: 23. Known pharma subsidiaries are mapped to their US-listed parent or ADR (e.g. Janssen -> JNJ, Novartis -> NVS). Companies shown as “n/a” are mostly foreign or privately held drug makers (mostly generics) with no US-listed stock. ...