Calendar

Week of Jan 26, 2026

Jan 27, 2026approval214d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →(daratumumab + hyaluronidase (human recombinant)) →fda approvals ↗

Jan 27, 2026approval214d agoNOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MSD MERCK CO. Form: FOR SUSPENSION, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗

Jan 27, 2026approval214d agoTAPENTADOL HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: HUMANWELL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 27, 2026approval214d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →POSACONAZOLE →fda approvals ↗

Jan 27, 2026approval214d agoFIDAXOMICIN — FDA approvalDificid

Sponsor: TORRENT. Form: TABLET. Route: ORAL

full page →Dificid →fda approvals ↗

Jan 27, 2026approval214d agoVYXEOS (CYTARABINE) — FDA approvalMeitheal Pharmaceuticals Inc

Sponsor: JAZZ PHARMS THERAP. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Jan 27, 2026approval214d agoMESNA — FDA approvalRiconpharma LLC

Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Jan 27, 2026approval214d agoTOPIRAMATE — FDA approvaltopiramate ER

Sponsor: NATCO. Form: TABLET. Route: ORAL

full page →topiramate ER →fda approvals ↗

Jan 27, 2026approval214d agoPROPRANOLOL HYDROCHLORIDE — FDA approvalpropranolol hydrochloride ER

Sponsor: MANKIND PHARMA. Form: TABLET. Route: ORAL

full page →propranolol hydrochloride ER →fda approvals ↗

Jan 27, 2026approval214d agoIDOSE TR (TRAVOPROST) — FDA approvalTRAVOPROST

Sponsor: GLAUKOS. Form: IMPLANT. Route: INTRACAMERAL

full page →TRAVOPROST →fda approvals ↗

Jan 27, 2026approval214d agoIDOSE TR (TRAVOPROST) — FDA approvalTRAVOPROST

Sponsor: GLAUKOS. Form: IMPLANT. Route: INTRACAMERAL

full page →TRAVOPROST →fda approvals ↗

Jan 27, 2026approval214d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗

Jan 27, 2026approval214d agoCAPECITABINE — FDA approvalArmas Pharmaceuticals Inc

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 27, 2026approval214d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

full page →vandetanib →fda approvals ↗

Jan 27, 2026approval214d agoPRIFTIN (RIFAPENTINE) — FDA approvalrifapentine

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →rifapentine →fda approvals ↗

Jan 27, 2026approval214d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Jan 27, 2026approval214d agoDEFLAZACORT — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: SUN PHARM INDS INC. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗

Jan 27, 2026approval214d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗

Jan 28, 2026approval213d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 28, 2026approval213d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Jan 28, 2026approval213d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Jan 28, 2026approval213d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗

Jan 28, 2026approval213d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗

Jan 28, 2026approval213d agoYUVEZZI (BRIMONIDINE TARTRATE) — FDA approvalBausch & Lomb Corp

Sponsor: VISUS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Jan 28, 2026approval213d agoDAYSEE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗

Jan 28, 2026approval213d agoISOSULFAN BLUE — FDA approvalISOSULFAN BLUE

Sponsor: MYLAN INSTITUTIONAL. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ISOSULFAN BLUE →fda approvals ↗

Jan 28, 2026approval213d agoCLOMIPRAMINE HYDROCHLORIDE — FDA approvalTruPharma LLC

Sponsor: TARO. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 28, 2026approval213d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →aripiprazole LA →fda approvals ↗

Jan 28, 2026approval213d agoSERTRALINE HYDROCHLORIDE — FDA approvalSERTRALINE HYDROCHLORIDE

Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL

full page →SERTRALINE HYDROCHLORIDE →fda approvals ↗

Jan 28, 2026approval213d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: UNICHEM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Jan 28, 2026approval213d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: UNICHEM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Jan 29, 2026approval212d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 29, 2026approval212d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Jan 29, 2026approval212d agoRIZAFILM (RIZATRIPTAN BENZOATE) — FDA approvalNAL Pharmaceuticals Ltd

Sponsor: GENSCO. Form: FILM. Route: ORAL

full page →fda approvals ↗

Jan 29, 2026approval212d agoSERTRALINE HYDROCHLORIDE — FDA approvalSERTRALINE HYDROCHLORIDE

Sponsor: ZYDUS LIFESCIENCES. Form: CAPSULE. Route: ORAL

full page →SERTRALINE HYDROCHLORIDE →fda approvals ↗

Jan 29, 2026approval212d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: RISING. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

Jan 29, 2026approval212d agoRILPIVIRINE HYDROCHLORIDE — FDA approvalrilpivirine hydrochloride ODT

Sponsor: SOMERSET THERAPS LLC. Form: TABLET. Route: ORAL

full page →rilpivirine hydrochloride ODT →fda approvals ↗

Jan 29, 2026approval212d agoLACOSAMIDE — FDA approvalAucta Pharmaceuticals Inc

Sponsor: REGCON HOLDINGS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Jan 29, 2026approval212d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

Jan 29, 2026approval212d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

Jan 29, 2026approval212d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

Jan 29, 2026approval212d agoXIMINO (MINOCYCLINE HYDROCHLORIDE) — FDA approvalOraPharma Inc

Sponsor: JOURNEY. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Jan 29, 2026approval212d agoLORBRENA (LORLATINIB) — FDA approvallorlatinib

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →lorlatinib →fda approvals ↗

Jan 29, 2026approval212d agoPRUCALOPRIDE SUCCINATE — FDA approvalPRUCALOPRIDE SUCCINATE

Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL

full page →PRUCALOPRIDE SUCCINATE →fda approvals ↗

Jan 30, 2026approval211d agoZYPREXA ZYDIS (OLANZAPINE) — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: CHEPLAPHARM. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

Jan 30, 2026approval211d agoBRIVARACETAM — FDA approvalUCB SA

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 30, 2026approval211d agoBRIVARACETAM — FDA approvalUCB SA

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 30, 2026approval211d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →fda approvals ↗

Jan 30, 2026approval211d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Jan 30, 2026approval211d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

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Week of Jan 26, 2026