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Week of Dec 8, 2025

50

Dec 8, 2025approval264d agoWINREVAIR (SOTATERCEPT-CSRK) — FDA approvalsotatercept

Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION

full page →sotatercept →fda approvals ↗

Dec 8, 2025approval264d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: LANNETT CO INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 8, 2025approval264d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: LANNETT CO INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 8, 2025approval264d agoEPINEPHRINE — FDA approvaladrenaline

Sponsor: AMNEAL. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →adrenaline →fda approvals ↗

Dec 8, 2025approval264d agoLINEZOLID — FDA approvalHQ Speciality Pharma

Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Dec 8, 2025approval264d agoESTRADIOL — FDA approvalestradiol ER

Sponsor: TEVA PHARMS USA INC. Form: INSERT. Route: VAGINAL

full page →estradiol ER →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 9, 2025approval263d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

Dec 9, 2025approval263d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

Dec 9, 2025approval263d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

Dec 9, 2025approval263d agoRYSTIGGO (ROZANOLIXIZUMAB-NOLI) — FDA approvalrozanolixizumab

Sponsor: UCB INC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →rozanolixizumab →fda approvals ↗

Dec 9, 2025approval263d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

Dec 9, 2025approval263d agoRECARBRIO (CILASTATIN SODIUM) — FDA approval(cilastatin sodium + imipenem + relebactam)

Sponsor: MSD MERCK CO. Form: POWDER. Route: INTRAVENOUS

full page →(cilastatin sodium + imipenem + relebactam) →fda approvals ↗

Dec 9, 2025approval263d agoTEPYLUTE (THIOTEPA) — FDA approvalSTI Pharma LLC

Sponsor: SHORLA. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Dec 9, 2025approval263d agoTEPYLUTE (THIOTEPA) — FDA approvalSTI Pharma LLC

Sponsor: SHORLA. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Dec 9, 2025approval263d agoIMITREX (SUMATRIPTAN) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: SPRAY. Route: NASAL

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

Dec 9, 2025approval263d agoIMITREX (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

Dec 9, 2025approval263d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: MACLEODS PHARMS LTD. Form: CAPSULE. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Dec 9, 2025approval263d agoVECURONIUM BROMIDE — FDA approvalVECURONIUM BROMIDE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →VECURONIUM BROMIDE →fda approvals ↗

Dec 10, 2025approval262d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗

Dec 10, 2025approval262d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →tocilizumab →fda approvals ↗

Dec 10, 2025approval262d agoMOMETASONE FUROATE — FDA approvalFougera Pharmaceuticals Inc

Sponsor: FOUGERA PHARMS. Form: OINTMENT. Route: TOPICAL

full page →fda approvals ↗

Dec 10, 2025approval262d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →tocilizumab →fda approvals ↗

Dec 10, 2025approval262d agoREZZAYO (REZAFUNGIN ACETATE) — FDA approvalrezafungin acetate

Sponsor: MUNDIPHARMA. Form: POWDER. Route: INTRAVENOUS

full page →rezafungin acetate →fda approvals ↗

Dec 10, 2025approval262d agoISOPROTERENOL HYDROCHLORIDE — FDA approvalISOPROTERENOL HYDROCHLORIDE

Sponsor: DEVA HOLDING AS. Form: INJECTABLE. Route: INJECTION

full page →ISOPROTERENOL HYDROCHLORIDE →fda approvals ↗

Dec 10, 2025approval262d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Dec 10, 2025approval262d agoLOTEPREDNOL ETABONATE AND TOBRAMYCIN (LOTEPREDNOL ETABONATE) — FDA approvalloteprednol etabonate

Sponsor: ALEMBIC. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

full page →loteprednol etabonate →fda approvals ↗

Dec 10, 2025approval262d agoTHALLOUS CHLORIDE TL 201 (THALLOUS CHLORIDE TL-201) — FDA approval

Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 10, 2025approval262d agoOMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE) — FDA approvalomeprazole DR

Sponsor: NOVITIUM PHARMA. Form: FOR SUSPENSION. Route: ORAL

full page →omeprazole DR →fda approvals ↗

Dec 11, 2025approval261d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 11, 2025approval261d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 11, 2025approval261d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalPERRIGO Co plc

Sponsor: LNK INTL INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 11, 2025approval261d agoDEFERIPRONE — FDA approvalSenores Pharmaceuticals Inc

Sponsor: SENORES PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 11, 2025approval261d agoBLUJEPA (GEPOTIDACIN MESYLATE) — FDA approvalgepotidacin mesylate

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →gepotidacin mesylate →fda approvals ↗

Dec 11, 2025approval261d agoCABERGOLINE — FDA approvalCABERGOLINE

Sponsor: INGENUS PHARMS LLC. Form: TABLET. Route: ORAL

full page →CABERGOLINE →fda approvals ↗

Dec 11, 2025approval261d agoMEROPENEM — FDA approvalHQ Speciality Pharma

Sponsor: BROOKS STERISCIENCE. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

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