Calendar

Week of Apr 6, 2026

Apr 8, 2026approval90d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Apr 8, 2026approval90d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 8, 2026approval90d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 8, 2026approval90d agoINGREZZA SPRINKLE (VALBENAZINE TOSYLATE) — FDA approvalVALBENAZINE TOSYLATE

Sponsor: NEUROCRINE. Form: CAPSULE. Route: ORAL

full page →VALBENAZINE TOSYLATE →fda approvals ↗

Apr 8, 2026approval90d agoHALOPERIDOL — FDA approvalHALOPERIDOL

Sponsor: AIPING PHARM INC. Form: TABLET. Route: ORAL

full page →HALOPERIDOL →fda approvals ↗

Apr 8, 2026approval90d agoLEVETIRACETAM — FDA approvalAprecia Pharmaceuticals LLC

Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Apr 8, 2026approval90d agoOFLOXACIN — FDA approvalOFLOXACIN

Sponsor: MICRO LABS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →OFLOXACIN →fda approvals ↗

Apr 8, 2026approval90d agoPROGESTERONE — FDA approvalPROGESTERONE

Sponsor: GLENMARK PHARMS LTD. Form: INSERT. Route: VAGINAL

full page →PROGESTERONE →fda approvals ↗

Apr 8, 2026approval90d agoELTROMBOPAG OLAMINE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ZENARA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 9, 2026approval89d agoMULTIPLE VITAMINS INJECTION ADULT (ALPHA-TOCOPHEROL ACETATE) — FDA approvalMULTIPLE VITAMINS INJECTION ADULT

Sponsor: APOTEX. Form: SOLUTION. Route: INTRAVENOUS

full page →MULTIPLE VITAMINS INJECTION ADULT →fda approvals ↗

Apr 9, 2026approval89d agoVABYSMO (FARICIMAB-SVOA) — FDA approvalfaricimab

Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INTRAVITREAL

full page →faricimab →fda approvals ↗

Apr 9, 2026approval89d agoFOSFOMYCIN TROMETHAMINE — FDA approvalFOSFOMYCIN TROMETHAMINE

Sponsor: AUCTA. Form: FOR SOLUTION. Route: ORAL

full page →FOSFOMYCIN TROMETHAMINE →fda approvals ↗

Apr 9, 2026approval89d agoDILTIAZEM HYDROCHLORIDE — FDA approvalBausch Health US LLC

Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 9, 2026approval89d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

Sponsor: IMPAX LABS INC. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 9, 2026approval89d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

Sponsor: IMPAX LABS INC. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 9, 2026approval89d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

Sponsor: IMPAX LABS INC. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 9, 2026approval89d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

Sponsor: IMPAX LABS INC. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 9, 2026approval89d agoDEFLAZACORT — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: UPSHER SMITH LABS. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗

Apr 9, 2026approval89d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

Sponsor: ALEMBIC. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →duloxetine hydrochloride DR →fda approvals ↗

Apr 9, 2026approval89d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 9, 2026approval89d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 9, 2026approval89d agoMESNA — FDA approvalMESNA

Sponsor: RISING. Form: INJECTABLE. Route: INTRAVENOUS

full page →MESNA →fda approvals ↗

Apr 9, 2026approval89d agoONUREG (AZACITIDINE) — FDA approvalBristol-Myers Squibb Co

Sponsor: BRISTOL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 9, 2026approval89d agoLEVETIRACETAM — FDA approvalAprecia Pharmaceuticals LLC

Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 9, 2026approval89d agoCOSOPT PF (DORZOLAMIDE HYDROCHLORIDE) — FDA approvalCosopt

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

full page →Cosopt →fda approvals ↗

Apr 9, 2026approval89d agoLAMOTRIGINE — FDA approvalTorrent Pharma Inc

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

full page →fda approvals ↗

Apr 9, 2026approval89d agoREZENOPY (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

Sponsor: SCIENTURE. Form: SPRAY. Route: NASAL

full page →naloxone hydrochloride →fda approvals ↗

Apr 9, 2026approval89d agoMULTIPLE VITAMINS INJECTION ADULT (ALPHA-TOCOPHEROL ACETATE) — FDA approvalMULTIPLE VITAMINS INJECTION ADULT

Sponsor: APOTEX. Form: SOLUTION. Route: INTRAVENOUS

full page →MULTIPLE VITAMINS INJECTION ADULT →fda approvals ↗

Apr 9, 2026approval89d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: RISING. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Apr 9, 2026approval89d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: RISING. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Apr 9, 2026approval89d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: RISING. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Apr 9, 2026approval89d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: RISING. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Apr 10, 2026approval88d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 10, 2026approval88d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

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

full page →LOSARTAN POTASSIUM →fda approvals ↗

Apr 10, 2026approval88d agoMETHYLPREDNISOLONE — FDA approvalPFIZER INC

Sponsor: TIANJIN TIANYAO. Form: TABLET. Route: ORAL

full page →fda approvals ↗