Calendar

Week of Apr 13, 2026

Apr 13, 2026approval139d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

Apr 13, 2026approval139d agoVANFLYTA (QUIZARTINIB DIHYDROCHLORIDE) — FDA approvalquizartinib dihydrochloride

Sponsor: DAIICHI SANKYO INC. Form: TABLET. Route: ORAL

full page →quizartinib dihydrochloride →fda approvals ↗

Apr 13, 2026approval139d agoLAMOTRIGINE — FDA approvalAlembic Pharmaceuticals Inc

Sponsor: ALEMBIC PHARMS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 13, 2026approval139d agoLAMOTRIGINE — FDA approvalAlembic Pharmaceuticals Inc

Sponsor: ALEMBIC PHARMS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 13, 2026approval139d agoLURASIDONE HYDROCHLORIDE — FDA approvalLURASIDONE HYDROCHLORIDE

Sponsor: TORRENT. Form: TABLET. Route: ORAL

full page →LURASIDONE HYDROCHLORIDE →fda approvals ↗

Apr 13, 2026approval139d agoLURASIDONE HYDROCHLORIDE — FDA approvalLURASIDONE HYDROCHLORIDE

Sponsor: TORRENT. Form: TABLET. Route: ORAL

full page →LURASIDONE HYDROCHLORIDE →fda approvals ↗

Apr 13, 2026approval139d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

Apr 13, 2026approval139d agoARTESUNATE — FDA approvalARTESUNATE

Sponsor: AMIVAS. Form: POWDER. Route: INTRAVENOUS

full page →ARTESUNATE →fda approvals ↗

Apr 13, 2026approval139d agoPIMOZIDE — FDA approvalPIMOZIDE

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

full page →PIMOZIDE →fda approvals ↗

Apr 13, 2026approval139d agoFILSPARI (SPARSENTAN) — FDA approvalsparsentan

Sponsor: TRAVERE. Form: TABLET. Route: ORAL

full page →sparsentan →fda approvals ↗

04/14/2026recall138d agoGood Brain Tonic recall: Food & Beverages, Foodborne Illness, Carbonated Soft Drinks

Good Brain Tonic 16 oz & 32 oz

full page →fda recalls ↗

Apr 14, 2026approval138d agoMILNACIPRAN HYDROCHLORIDE — FDA approvalMILNACIPRAN HYDROCHLORIDE

Sponsor: BRECKENRIDGE. Form: TABLET. Route: ORAL

full page →MILNACIPRAN HYDROCHLORIDE →fda approvals ↗

Apr 14, 2026approval138d agoMILNACIPRAN HYDROCHLORIDE — FDA approvalMILNACIPRAN HYDROCHLORIDE

Sponsor: BRECKENRIDGE. Form: TABLET. Route: ORAL

full page →MILNACIPRAN HYDROCHLORIDE →fda approvals ↗

Apr 14, 2026approval138d agoMILNACIPRAN HYDROCHLORIDE — FDA approvalMILNACIPRAN HYDROCHLORIDE

Sponsor: BRECKENRIDGE. Form: TABLET. Route: ORAL

full page →MILNACIPRAN HYDROCHLORIDE →fda approvals ↗

Apr 14, 2026approval138d agoDANZITEN (NILOTINIB TARTRATE) — FDA approvalDANZITEN

Sponsor: AZURITY. Form: TABLET. Route: ORAL

full page →DANZITEN →fda approvals ↗

Apr 14, 2026approval138d agoSONAZINE (CHLORPROMAZINE HYDROCHLORIDE) — FDA approvalSaptalis Pharmaceuticals LLC

Sponsor: SAPTALIS PHARMS. Form: CONCENTRATE. Route: ORAL

full page →fda approvals ↗

Apr 14, 2026approval138d agoRYTELO (IMETELSTAT SODIUM) — FDA approvalimetelstat sodium

Sponsor: GERON. Form: POWDER. Route: INTRAVENOUS

full page →imetelstat sodium →fda approvals ↗

Apr 14, 2026approval138d agoMILNACIPRAN HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Apr 14, 2026approval138d agoBOSENTAN — FDA approvalBOSENTAN

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

full page →BOSENTAN →fda approvals ↗

Apr 14, 2026approval138d agoBOSENTAN — FDA approvalBOSENTAN

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

full page →BOSENTAN →fda approvals ↗

Apr 14, 2026approval138d agoCANAGLIFLOZIN — FDA approvalCANAGLIFLOZIN

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →CANAGLIFLOZIN →fda approvals ↗

Apr 14, 2026approval138d agoLACTULOSE — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

Apr 14, 2026approval138d agoABREVA (DOCOSANOL) — FDA approvalPL Developments Copiague LLC

Sponsor: HALEON US HOLDINGS. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Apr 14, 2026approval138d agoBOSENTAN — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

Apr 14, 2026approval138d agoBOSENTAN — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

Apr 15, 2026approval137d agoGLYCEROL PHENYLBUTYRATE — FDA approvalLupin Ltd

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

full page →fda approvals ↗

Apr 15, 2026approval137d agoDIACOMIT (STIRIPENTOL) — FDA approvalstiripentol

Sponsor: BIOCODEX SA. Form: CAPSULE. Route: ORAL

full page →stiripentol →fda approvals ↗

Apr 15, 2026approval137d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 15, 2026approval137d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

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

full page →ALENDRONATE SODIUM →fda approvals ↗

Apr 15, 2026approval137d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 15, 2026approval137d agoMETHOTREXATE SODIUM — FDA approvalMaxtrex

Sponsor: ALEMBIC. Form: INJECTABLE. Route: INJECTION

full page →Maxtrex →fda approvals ↗

Apr 15, 2026approval137d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 15, 2026approval137d agoWAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approvaleplontersen sodium

Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS

full page →eplontersen sodium →fda approvals ↗

Apr 15, 2026approval137d agoGLYCEROL PHENYLBUTYRATE — FDA approvalGLYCEROL PHENYLBUTYRATE

Sponsor: AUROBINDO PHARMA. Form: LIQUID

full page →GLYCEROL PHENYLBUTYRATE →fda approvals ↗

Apr 15, 2026approval137d agoRAMELTEON — FDA approvalRAMELTEON

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

full page →RAMELTEON →fda approvals ↗

Apr 15, 2026approval137d agoALENDRONATE SODIUM — FDA approvalOrganon & Co.

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

full page →fda approvals ↗

Apr 15, 2026approval137d agoSODIUM BICARBONATE — FDA approvalSODIUM BICARBONATE

Sponsor: ASPIRO. Form: SOLUTION. Route: INTRAVENOUS

full page →SODIUM BICARBONATE →fda approvals ↗

Apr 15, 2026approval137d agoGLYCEROL PHENYLBUTYRATE — FDA approvalGLYCEROL PHENYLBUTYRATE

Sponsor: MSN. Form: LIQUID. Route: ORAL

full page →GLYCEROL PHENYLBUTYRATE →fda approvals ↗

Apr 15, 2026approval137d agoDEXTROMETHORPHAN POLISTIREX — FDA approvalDEXTROMETHORPHAN POLISTIREX

Sponsor: AUROBINDO PHARMA LTD. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL

full page →DEXTROMETHORPHAN POLISTIREX →fda approvals ↗

Apr 15, 2026approval137d agoDIACOMIT (STIRIPENTOL) — FDA approvalstiripentol

Sponsor: BIOCODEX SA. Form: FOR SUSPENSION. Route: ORAL

full page →stiripentol →fda approvals ↗

Apr 15, 2026approval137d agoZOLEDRONIC ACID — FDA approvalNOVARTIS AG

Sponsor: MYLAN LABS LTD. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Apr 15, 2026approval137d agoSTELARA (USTEKINUMAB) — FDA approvalustekinumab

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

full page →ustekinumab →fda approvals ↗

Apr 15, 2026approval137d agoATROPINE SULFATE — FDA approvalEdenbridge Pharmaceuticals LLC

Sponsor: EDENBRIDGE PHARMS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Apr 15, 2026approval137d agoBUSPIRONE HYDROCHLORIDE — FDA approvalOxford Pharmaceuticals LLC

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

full page →fda approvals ↗

Apr 15, 2026approval137d agoCOLESTIPOL HYDROCHLORIDE — FDA approvalCarnegie Pharmaceuticals LLC

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

full page →fda approvals ↗

Apr 15, 2026approval137d agoCOLESTIPOL HYDROCHLORIDE — FDA approvalCarnegie Pharmaceuticals LLC

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

full page →fda approvals ↗

Apr 15, 2026approval137d agoCOLESTIPOL HYDROCHLORIDE — FDA approvalCarnegie Pharmaceuticals LLC

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

full page →fda approvals ↗

Apr 15, 2026approval137d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)

full page →ONTRUZANT →fda approvals ↗

Apr 15, 2026approval137d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE. Route: INJECTION

full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗

Apr 15, 2026approval137d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

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Week of Apr 13, 2026