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Week of Apr 13, 2026

36

Apr 15, 2026approval86d agoDEXTROMETHORPHAN POLISTIREX — FDA approvalDEXTROMETHORPHAN POLISTIREX

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

full page →DEXTROMETHORPHAN POLISTIREX →fda approvals ↗

Apr 15, 2026approval86d agoDIACOMIT (STIRIPENTOL) — FDA approvalstiripentol

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

full page →stiripentol →fda approvals ↗

Apr 15, 2026approval86d agoZOLEDRONIC ACID — FDA approvalNOVARTIS AG

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

full page →fda approvals ↗

Apr 15, 2026approval86d agoSTELARA (USTEKINUMAB) — FDA approvalustekinumab

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

full page →ustekinumab →fda approvals ↗

Apr 15, 2026approval86d agoATROPINE SULFATE — FDA approvalEdenbridge Pharmaceuticals LLC

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

full page →fda approvals ↗

Apr 15, 2026approval86d agoBUSPIRONE HYDROCHLORIDE — FDA approvalOxford Pharmaceuticals LLC

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

full page →fda approvals ↗

Apr 15, 2026approval86d agoCOLESTIPOL HYDROCHLORIDE — FDA approvalCarnegie Pharmaceuticals LLC

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

full page →fda approvals ↗

Apr 15, 2026approval86d agoCOLESTIPOL HYDROCHLORIDE — FDA approvalCarnegie Pharmaceuticals LLC

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

full page →fda approvals ↗

Apr 15, 2026approval86d agoCOLESTIPOL HYDROCHLORIDE — FDA approvalCarnegie Pharmaceuticals LLC

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

full page →fda approvals ↗

Apr 15, 2026approval86d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

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

full page →ONTRUZANT →fda approvals ↗

Apr 15, 2026approval86d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

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

full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗

Apr 15, 2026approval86d 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 ↗

Apr 15, 2026approval86d 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 ↗

Apr 15, 2026approval86d 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 ↗

Apr 15, 2026approval86d 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 ↗

Apr 15, 2026approval86d 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 ↗

Apr 15, 2026approval86d 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 ↗

Apr 15, 2026approval86d 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 ↗

Apr 15, 2026approval86d agoDATSCAN (IOFLUPANE I-123) — FDA approval

Sponsor: GE HLTHCARE INC. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Apr 15, 2026approval86d agoITOVEBI (INAVOLISIB) — FDA approvalinavolisib

Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL

full page →inavolisib →fda approvals ↗

Apr 16, 2026approval85d agoBRIMONIDINE TARTRATE — FDA approvalLumify

Sponsor: MANKIND PHARMA. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Lumify →fda approvals ↗

Apr 16, 2026approval85d agoSELEXIPAG — FDA approvalSELEXIPAG

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

full page →SELEXIPAG →fda approvals ↗

Apr 16, 2026approval85d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →dupilumab →fda approvals ↗

Apr 17, 2026approval84d agoSODIUM ACETATE — FDA approvalSODIUM ACETATE

Sponsor: EXTROVIS. Form: SOLUTION. Route: INTRAVENOUS

full page →SODIUM ACETATE →fda approvals ↗

Apr 17, 2026approval84d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 17, 2026approval84d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 17, 2026approval84d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 17, 2026approval84d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 17, 2026approval84d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: QUAGEN. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Apr 17, 2026approval84d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

Apr 17, 2026approval84d agoCALCIPOTRIENE — FDA approvalPrasco LLC

Sponsor: GLENMARK SPECLT. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Apr 17, 2026approval84d agoESOMEPRAZOLE MAGNESIUM — FDA approvalesomeprazole magnesium DR

Sponsor: MARKSANS PHARMA. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →esomeprazole magnesium DR →fda approvals ↗

Apr 17, 2026approval84d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Apr 17, 2026approval84d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Apr 17, 2026approval84d agoTETRACYCLINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals of New York LLC

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

full page →fda approvals ↗

Apr 17, 2026approval84d agoTETRACYCLINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals of New York LLC

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

full page →fda approvals ↗

Week of Apr 20, 2026

3

Apr 20, 2026approval81d agoCANAGLIFLOZIN — FDA approvalCANAGLIFLOZIN

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

full page →CANAGLIFLOZIN →fda approvals ↗

Apr 20, 2026approval

Week of Apr 27, 2026

6

Apr 30, 2026filing71d agoXbrane Biopharma AB — ranibizumab biosimilar (NDA/BLA Filing (US))ranibizumab biosimilar

Therapy area: Ophthalmology. Indication: Wet (Neovascular / Exudative) Macular Degeneration

full page →ranibizumab biosimilar →source: globaldata

Apr 30, 2026filing

Date TBD

5

TBDapprovalOZURDEX (DEXAMETHASONE) — FDA approvaldexamethasone LA

Sponsor: ABBVIE. Form: IMPLANT. Route: INTRAVITREAL

full page →dexamethasone LA →fda approvals ↗

TBDapproval

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