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Week of Apr 13, 2026

23

Apr 15, 2026approval87d 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, 2026approval87d 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, 2026approval87d 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, 2026approval87d 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, 2026approval87d 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, 2026approval87d agoDATSCAN (IOFLUPANE I-123) — FDA approval

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

full page →fda approvals ↗

Apr 15, 2026approval87d agoITOVEBI (INAVOLISIB) — FDA approvalinavolisib

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

full page →inavolisib →fda approvals ↗

Apr 16, 2026approval86d agoBRIMONIDINE TARTRATE — FDA approvalLumify

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

full page →Lumify →fda approvals ↗

Apr 16, 2026approval86d agoSELEXIPAG — FDA approvalSELEXIPAG

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

full page →SELEXIPAG →fda approvals ↗

Apr 16, 2026approval86d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗

Apr 17, 2026approval85d agoSODIUM ACETATE — FDA approvalSODIUM ACETATE

Sponsor: EXTROVIS. Form: SOLUTION. Route: INTRAVENOUS

full page →SODIUM ACETATE →fda approvals ↗

Apr 17, 2026approval85d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

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

full page →fda approvals ↗

Apr 17, 2026approval85d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

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

full page →fda approvals ↗

Apr 17, 2026approval85d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

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

full page →fda approvals ↗

Apr 17, 2026approval85d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

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

full page →fda approvals ↗

Apr 17, 2026approval85d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: QUAGEN. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Apr 17, 2026approval85d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

Apr 17, 2026approval85d agoCALCIPOTRIENE — FDA approvalPrasco LLC

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

full page →fda approvals ↗

Apr 17, 2026approval85d agoESOMEPRAZOLE MAGNESIUM — FDA approvalesomeprazole magnesium DR

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

full page →esomeprazole magnesium DR →fda approvals ↗

Apr 17, 2026approval85d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 17, 2026approval85d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 17, 2026approval85d agoTETRACYCLINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals of New York LLC

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

full page →fda approvals ↗

Apr 17, 2026approval85d 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, 2026approval82d agoCANAGLIFLOZIN — FDA approvalCANAGLIFLOZIN

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

full page →CANAGLIFLOZIN →fda approvals ↗

Apr 20, 2026approval

Week of Jul 6, 2026

1

07/08/2026adcom3d agoAdvisory Committee Calendar

This page contains notices of advisory committee meetings. Refer to the individual meeting link below for more information on the anticipated format of each meeting. For previous years' advisory committee calendars, see the FDA Archive.

full page →fda adcom ↗

Date TBD

2

TBDapprovalOZURDEX (DEXAMETHASONE) — FDA approvaldexamethasone LA

Sponsor: ABBVIE. Form: IMPLANT. Route: INTRAVITREAL

full page →dexamethasone LA →fda approvals ↗

TBDapproval

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