Fda

FDA drug approvals recorded by openFDA between 2026-09-13 and 2026-09-27, newest first. Company is the first listed manufacturer; tickers link to Seeking Alpha. Approval Date Company Drug Ticker 2026-09-22 Alembic Pharmaceuticals Limited TELMISARTAN AND AMLODIPINE n/a 2026-09-22 Amici Pharma, Inc. RISPERIDONE n/a 2026-09-22 Bayer HealthCare Pharmaceuticals Inc. NUBEQA BAYRY 2026-09-22 Eugia US LLC KETAMINE HYDROCHLORIDE n/a 2026-09-22 GLENMARK PHARMACEUTICALS INC., USA EPINEPHRINE n/a 2026-09-22 Novartis Pharmaceuticals Corporation SCEMBLIX NVS 2026-09-21 Merck Sharp & Dohme LLC WINREVAIR MRK 2026-09-18 AMNEAL LANREOTIDE ACETATE AMNL 2026-09-18 BAXTER HLTHCARE CORP ROCURONIUM BROMIDE BAX 2026-09-18 Eli Lilly and Company INLURIYO LLY 2026-09-18 Eli Lilly and Company VERZENIO LLY 2026-09-18 HIKMA DEFLAZACORT n/a 2026-09-18 INTRABIO AQNEURSA n/a 2026-09-18 Ipsen Biopharmaceuticals, Inc. SOHONOS n/a 2026-09-18 Trifluent Pharma LLC DICLOFENAC POTASSIUM n/a 2026-09-17 Actavis Pharma, Inc. DEXTROAMPHETAMINE SULFATE n/a 2026-09-17 Alembic Pharmaceuticals Limited CLONIDINE HYDROCHLORIDE n/a 2026-09-17 APOTEX LEVOCETIRIZINE DIHYDROCHLORIDE n/a 2026-09-17 Apotex Corp ICOSAPENT ETHYL n/a 2026-09-17 AUROBINDO PHARMA LTD CYCLOSPORINE n/a 2026-09-17 CIPLA CALCIUM GLUCONATE IN SODIUM CHLORIDE n/a 2026-09-17 FRESENIUS KABI USA DAPTOMYCIN n/a 2026-09-17 JANSSEN PHARMS SPRAVATO JNJ 2026-09-17 LUPIN AMABELZ n/a 2026-09-17 Teva Parenteral Medicines, Inc. PALONOSETRON HYDROCHLORIDE TEVA 2026-09-17 Zydus Pharmaceuticals USA Inc. LACOSAMIDE n/a 2026-09-16 American Health Packaging GABAPENTIN AHR 2026-09-16 ASTRAZENECA TRUQAP AZN 2026-09-16 Aurobindo Pharma Limited MELOXICAM n/a 2026-09-16 Bayer HealthCare Pharmaceuticals Inc. KERENDIA BAYRY 2026-09-16 Chartwell RX, LLC CALCITRIOL n/a 2026-09-16 Fresenius Kabi USA, LLC GLUCAGON n/a 2026-09-16 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. TRANEXAMIC ACID HRTG 2026-09-16 Macleods Pharmaceuticals Limited OLANZAPINE n/a 2026-09-16 Novartis Pharmaceuticals Corporation ZORTRESS NVS 2026-09-16 NUVATION IBTROZI NUVB 2026-09-16 STRIDES PHARMA DEXTROAMPHETAMINE SULFATE n/a 2026-09-16 U.S. Pharmaceuticals XELJANZ n/a 2026-09-16 U.S. Pharmaceuticals XELJANZ XR n/a 2026-09-15 ACTAVIS TOTOWA LETROZOLE n/a 2026-09-15 CHARTWELL RX PRAMIPEXOLE DIHYDROCHLORIDE n/a 2026-09-15 DIFGEN PHARMS EPINEPHRINE n/a 2026-09-15 MACLEODS PHARMS MILNACIPRAN HYDROCHLORIDE n/a 2026-09-15 Meitheal Pharmaceuticals Inc. GARZULYS n/a 2026-09-15 Meitheal Pharmaceuticals Inc. TIGECYCLINE n/a 2026-09-15 Mylan Pharmaceuticals Inc. AMNESTEEM VTRS 2026-09-15 Otsuka America Pharmaceutical, Inc. JYNARQUE n/a 2026-09-15 Sandoz Inc TIGECYCLINE SDZWF 2026-09-15 STRIDES PHARMA MILNACIPRAN HYDROCHLORIDE n/a 2026-09-15 SUN PHARM INDUSTRIES DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE n/a 2026-09-15 TEVA PHARMS CARBAMAZEPINE TEVA 2026-09-15 Upsher-Smith Laboratories, LLC TESTOSTERONE n/a 2026-09-15 ZYDUS LIFESCIENCES TRETINOIN n/a 2026-09-14 AJANTA PHARMA LTD HALOPERIDOL n/a 2026-09-14 Alembic Pharmaceuticals Inc. ITRACONAZOLE n/a 2026-09-14 ALVOGEN PRIMAQUINE PHOSPHATE n/a 2026-09-14 Amneal Pharmaceuticals LLC ITRACONAZOLE AMNL 2026-09-14 ASTRAZENECA TAGRISSO AZN 2026-09-14 AUROLIFE PHARMA LLC BECLOMETHASONE DIPROPIONATE n/a 2026-09-14 Cranbury Pharmaceuticals, LLC DOXYCYCLINE HYCLATE n/a 2026-09-14 CURIUM BEXLUTRY n/a 2026-09-14 GENENTECH INC EVRYSDI RHHBY 2026-09-14 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. COLISTIMETHATE SODIUM HRTG 2026-09-14 Micro Labs Limited CLOBAZAM n/a 2026-09-14 SAGENT PHARMS INC COLISTIMETHATE SODIUM n/a 2026-09-14 Unichem Pharmaceuticals (USA), Inc. PRIMAQUINE PHOSPHATE n/a 2026-09-14 VistaPharm, LLC METHADONE HYDROCHLORIDE n/a 2026-09-14 Xiromed LLC NEOSTIGMINE METHYLSULFATE n/a 2026-09-14 ZYDUS LIFESCIENCES LETROZOLE n/a 2026-09-14 ZYDUS PHARMS EPINEPHRINE n/a Only the 70 most relevant rows are shown. Approved applications (originals and supplements) in this window: 73; rows shown: 70; tickers identified: 22. 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. ...

FDA drug approvals recorded by openFDA between 2026-09-06 and 2026-09-20, newest first. Company is the first listed manufacturer; tickers link to Seeking Alpha. Approval Date Company Drug Ticker 2026-09-18 AMNEAL LANREOTIDE ACETATE AMNL 2026-09-18 BAXTER HLTHCARE CORP ROCURONIUM BROMIDE BAX 2026-09-18 Eli Lilly and Company INLURIYO LLY 2026-09-18 Eli Lilly and Company VERZENIO LLY 2026-09-18 HIKMA DEFLAZACORT n/a 2026-09-18 INTRABIO AQNEURSA n/a 2026-09-18 Ipsen Biopharmaceuticals, Inc. SOHONOS n/a 2026-09-18 Trifluent Pharma LLC DICLOFENAC POTASSIUM n/a 2026-09-17 Actavis Pharma, Inc. DEXTROAMPHETAMINE SULFATE n/a 2026-09-17 Alembic Pharmaceuticals Limited CLONIDINE HYDROCHLORIDE n/a 2026-09-17 APOTEX LEVOCETIRIZINE DIHYDROCHLORIDE n/a 2026-09-17 Apotex Corp ICOSAPENT ETHYL n/a 2026-09-17 AUROBINDO PHARMA LTD CYCLOSPORINE n/a 2026-09-17 CIPLA CALCIUM GLUCONATE IN SODIUM CHLORIDE n/a 2026-09-17 FRESENIUS KABI USA DAPTOMYCIN n/a 2026-09-17 JANSSEN PHARMS SPRAVATO JNJ 2026-09-17 LUPIN AMABELZ n/a 2026-09-17 Teva Parenteral Medicines, Inc. PALONOSETRON HYDROCHLORIDE TEVA 2026-09-17 Zydus Pharmaceuticals USA Inc. LACOSAMIDE n/a 2026-09-16 American Health Packaging GABAPENTIN AHR 2026-09-16 AstraZeneca Pharmaceuticals LP TRUQAP AZN 2026-09-16 Aurobindo Pharma Limited MELOXICAM n/a 2026-09-16 Bayer HealthCare Pharmaceuticals Inc. KERENDIA BAYRY 2026-09-16 Chartwell RX, LLC CALCITRIOL n/a 2026-09-16 Fresenius Kabi USA, LLC GLUCAGON n/a 2026-09-16 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. TRANEXAMIC ACID HRTG 2026-09-16 Macleods Pharmaceuticals Limited OLANZAPINE n/a 2026-09-16 Novartis Pharmaceuticals Corporation ZORTRESS NVS 2026-09-16 NUVATION IBTROZI NUVB 2026-09-16 Pfizer Laboratories Div Pfizer Inc XELJANZ PFE 2026-09-16 Pfizer Laboratories Div Pfizer Inc XELJANZ XR PFE 2026-09-16 STRIDES PHARMA DEXTROAMPHETAMINE SULFATE n/a 2026-09-15 ACTAVIS TOTOWA LETROZOLE n/a 2026-09-15 CHARTWELL RX PRAMIPEXOLE DIHYDROCHLORIDE n/a 2026-09-15 DIFGEN PHARMS EPINEPHRINE n/a 2026-09-15 Eugia US LLC KETAMINE HYDROCHLORIDE n/a 2026-09-15 MACLEODS PHARMS MILNACIPRAN HYDROCHLORIDE n/a 2026-09-15 Meitheal Pharmaceuticals Inc. GARZULYS n/a 2026-09-15 Meitheal Pharmaceuticals Inc. TIGECYCLINE n/a 2026-09-15 Mylan Pharmaceuticals Inc. AMNESTEEM VTRS 2026-09-15 Otsuka America Pharmaceutical, Inc. JYNARQUE n/a 2026-09-15 Sandoz Inc TIGECYCLINE SDZWF 2026-09-15 STRIDES PHARMA MILNACIPRAN HYDROCHLORIDE n/a 2026-09-15 SUN PHARM INDUSTRIES DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE n/a 2026-09-15 TEVA PHARMS CARBAMAZEPINE TEVA 2026-09-15 Upsher-Smith Laboratories, LLC TESTOSTERONE n/a 2026-09-15 ZYDUS LIFESCIENCES TRETINOIN n/a 2026-09-14 AJANTA PHARMA LTD HALOPERIDOL n/a 2026-09-14 Alembic Pharmaceuticals Inc. ITRACONAZOLE n/a 2026-09-14 ALVOGEN PRIMAQUINE PHOSPHATE n/a 2026-09-14 Amneal Pharmaceuticals LLC ITRACONAZOLE AMNL 2026-09-14 ASTRAZENECA TAGRISSO AZN 2026-09-14 AUROLIFE PHARMA LLC BECLOMETHASONE DIPROPIONATE n/a 2026-09-14 Cranbury Pharmaceuticals, LLC DOXYCYCLINE HYCLATE n/a 2026-09-14 CURIUM BEXLUTRY n/a 2026-09-14 Genentech, Inc. EVRYSDI RHHBY 2026-09-14 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. COLISTIMETHATE SODIUM HRTG 2026-09-14 Micro Labs Limited CLOBAZAM n/a 2026-09-14 SAGENT PHARMS INC COLISTIMETHATE SODIUM n/a 2026-09-14 Unichem Pharmaceuticals (USA), Inc. PRIMAQUINE PHOSPHATE n/a 2026-09-14 VistaPharm, LLC METHADONE HYDROCHLORIDE n/a 2026-09-14 Xiromed LLC NEOSTIGMINE METHYLSULFATE n/a 2026-09-14 ZYDUS LIFESCIENCES LETROZOLE n/a 2026-09-14 ZYDUS PHARMS EPINEPHRINE n/a 2026-09-11 Amgen, Inc IMDELLTRA (AMG757) AMGN 2026-09-11 APOTEX ITRACONAZOLE n/a 2026-09-11 Chartwell Governmental & Specialty RX, LLC. ETHOSUXIMIDE n/a 2026-09-11 Exelan Pharmaceuticals, Inc. GABAPENTIN n/a 2026-09-11 Kythera Biopharmaceuticals Inc. KYBELLA n/a 2026-09-11 MSN DASATINIB n/a 2026-09-11 Pharming Healthcare Inc. JOENJA PHAR 2026-09-11 RICONPHARMA LLC SIPONIMOD n/a 2026-09-11 RISING PENTOSTATIN n/a 2026-09-11 SCHOLAR ROCK INC ISEMBYLD SRRK 2026-09-11 SpecGx LLC MORPHINE SULFATE n/a 2026-09-11 Sun Pharmaceutical Industries, Inc. CARBIDOPA AND LEVODOPA n/a 2026-09-11 TELIX PHARMACEUTICALS US INC PIXCLARA TLX 2026-09-11 Teva Parenteral Medicines, Inc. PACLITAXEL TEVA 2026-09-11 Teva Pharmaceuticals USA, Inc. CARBIDOPA AND LEVODOPA TEVA 2026-09-11 The Fresh Test, LLC POLYETHYLENE GLYCOL 3350 n/a 2026-09-10 Alembic Pharmaceuticals Limited ASENAPINE n/a 2026-09-10 AUROBINDO PHARMA LTD ISOTRETINOIN n/a 2026-09-10 Camber Pharmaceuticals, Inc. LISDEXAMFETAMINE DIMESYLATE n/a 2026-09-10 Granules Pharmaceuticals Inc. LISDEXAMFETAMINE DIMESYLATE n/a 2026-09-10 HIKMA HYDROMORPHONE HYDROCHLORIDE n/a 2026-09-10 Hikma Pharmaceuticals USA Inc. HYDROMORPHONE HYDROCHLORIDE n/a 2026-09-10 MAYNE PHARMA ANNOVERA n/a 2026-09-10 RUBICON RESEARCH SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE n/a 2026-09-10 Solco Healthcare US,LLC LISDEXAMFETAMINE DIMESYLATE n/a 2026-09-09 Alembic Pharmaceuticals Limited ROPINIROLE n/a 2026-09-09 BAYER HEALTHCARE HYRNUO BAYRY 2026-09-09 BIOFRONTERA 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 Only the 95 most relevant rows are shown. Approved applications (originals and supplements) in this window: 100; rows shown: 95; tickers identified: 28. 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. ...

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. ...