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Week of Jan 12, 2026

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Jan 14, 2026approval227d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: LAURUS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 14, 2026approval227d agoELTROMBOPAG OLAMINE — FDA approvalELTROMBOPAG OLAMINE

Sponsor: SOMERSET THERAPS LLC. Form: TABLET

full page →ELTROMBOPAG OLAMINE →fda approvals ↗

Jan 14, 2026approval227d agoELTROMBOPAG OLAMINE — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

Jan 14, 2026approval227d agoLIRAGLUTIDE — FDA approvalNovo Nordisk Inc

Sponsor: ORBICULAR. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Jan 14, 2026approval227d agoTOREMIFENE CITRATE — FDA approvalTOREMIFENE CITRATE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →TOREMIFENE CITRATE →fda approvals ↗

Jan 14, 2026approval227d agoMYCOPHENOLATE SODIUM — FDA approvalmycophenolate sodium DR

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →mycophenolate sodium DR →fda approvals ↗

Jan 14, 2026approval227d agoROGAINE EXTRA STRENGTH (FOR MEN) (MINOXIDIL) — FDA approvalVeradermics, Inc

Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

Jan 14, 2026approval227d agoSITAGLIPTIN PHOSPHATE — FDA approvalSITAGLIPTIN PHOSPHATE

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →SITAGLIPTIN PHOSPHATE →fda approvals ↗

Jan 14, 2026approval227d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Jan 14, 2026approval227d agoMETHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM) — FDA approvalPFIZER INC

Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jan 14, 2026approval227d agoMETHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM) — FDA approvalPFIZER INC

Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jan 14, 2026approval227d agoANAGRELIDE HYDROCHLORIDE — FDA approvalANAGRELIDE HYDROCHLORIDE

Sponsor: RISING. Form: CAPSULE. Route: ORAL

full page →ANAGRELIDE HYDROCHLORIDE →fda approvals ↗

Jan 15, 2026approval226d agoOSELTAMIVIR PHOSPHATE — FDA approvalOSELTAMIVIR PHOSPHATE

Sponsor: AJANTA PHARMA LTD. Form: FOR SUSPENSION. Route: ORAL

full page →OSELTAMIVIR PHOSPHATE →fda approvals ↗

Jan 15, 2026approval226d agoREZUROCK (BELUMOSUDIL MESYLATE) — FDA approvalbelumosudil mesylate

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

full page →belumosudil mesylate →fda approvals ↗

Jan 15, 2026approval226d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 15, 2026approval226d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 15, 2026approval226d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 15, 2026approval226d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 15, 2026approval226d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 15, 2026approval226d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 15, 2026approval226d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 15, 2026approval226d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: MOUNTAIN. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 15, 2026approval226d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

full page →OTULFI →fda approvals ↗

Jan 15, 2026approval226d agoNAPROXEN SODIUM — FDA approvalNAPROXEN SODIUM

Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗

Jan 15, 2026approval226d agoFLUOXETINE HYDROCHLORIDE — FDA approvalFLUOXETINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →FLUOXETINE HYDROCHLORIDE →fda approvals ↗

Jan 15, 2026approval226d agoFILKRI (FILGRASTIM-LAHA) — FDA approvalfilgrastim biosimilar

Sponsor: ACCORD BIOPHARMA INC.. Form: INJECTABLE. Route: INJECTION

full page →filgrastim biosimilar →fda approvals ↗

Jan 15, 2026approval226d agoFLUOXETINE HYDROCHLORIDE — FDA approvalFLUOXETINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →FLUOXETINE HYDROCHLORIDE →fda approvals ↗

Jan 15, 2026approval226d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalMacleods Pharmaceuticals Ltd

Sponsor: WATSON LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 15, 2026approval226d agoTEPADINA AND SODIUM CHLORIDE (THIOTEPA) — FDA approvalRevalesio Corp

Sponsor: ADIENNE SA. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Jan 15, 2026approval226d agoOXALIPLATIN — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: SHANDONG. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Jan 15, 2026approval226d agoALVAIZ (ELTROMBOPAG CHOLINE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 16, 2026approval225d agoZYNLONTA (LONCASTUXIMAB TESIRINE-LPYL) — FDA approvalloncastuximab tesirine

Sponsor: ADC Therapeutics SA. Form: INJECTABLE. Route: INJECTION

full page →loncastuximab tesirine →fda approvals ↗

Jan 16, 2026approval225d agoBRIUMVI (UBLITUXIMAB-XIIY) — FDA approvalublituximab

Sponsor: TG THERAPEUTICS, INC. Form: INJECTABLE. Route: INTRAVENOUS

full page →ublituximab →fda approvals ↗

Jan 16, 2026approval225d agoLEQEMBI (LECANEMAB-IRMB) — FDA approvallecanemab

Sponsor: EISAI INC. Form: INJECTABLE. Route: INJECTION

full page →lecanemab →fda approvals ↗

Jan 16, 2026approval225d agoRYKINDO (RISPERIDONE) — FDA approvalDelpor Inc

Sponsor: SHANDONG LUYE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →fda approvals ↗

Jan 16, 2026approval225d agoIMPLANON (ETONOGESTREL) — FDA approvaletonogestrel CR

Sponsor: ORGANON. Form: IMPLANT. Route: IMPLANTATION

full page →etonogestrel CR →fda approvals ↗

Jan 16, 2026approval225d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

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

full page →FINGOLIMOD HYDROCHLORIDE →fda approvals ↗

Jan 16, 2026approval225d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗

Jan 16, 2026approval225d agoPRUCALOPRIDE SUCCINATE — FDA approvalPRUCALOPRIDE SUCCINATE

Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL

full page →PRUCALOPRIDE SUCCINATE →fda approvals ↗

Jan 17, 2026approval224d agoDOXYCYCLINE — FDA approvalPrasco LLC

Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 17, 2026approval224d agoDOXYCYCLINE — FDA approvalPrasco LLC

Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 17, 2026approval224d agoDOXYCYCLINE — FDA approvalPrasco LLC

Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 17, 2026approval224d agoDOXYCYCLINE — FDA approvalPrasco LLC

Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 17, 2026approval224d agoDOXYCYCLINE — FDA approvalPrasco LLC

Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 17, 2026approval224d agoCLINDAMYCIN HYDROCHLORIDE — FDA approvalMicro Labs USA Inc

Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 17, 2026approval224d agoCLINDAMYCIN HYDROCHLORIDE — FDA approvalMicro Labs USA Inc

Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 17, 2026approval224d agoCLINDAMYCIN HYDROCHLORIDE — FDA approvalMicro Labs USA Inc

Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 17, 2026approval224d agoCLINDAMYCIN HYDROCHLORIDE — FDA approvalMicro Labs USA Inc

Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 17, 2026approval224d agoCLINDAMYCIN HYDROCHLORIDE — FDA approvalMicro Labs USA Inc

Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 17, 2026approval224d agoCLINDAMYCIN HYDROCHLORIDE — FDA approvalMicro Labs USA Inc

Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

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