Calendar

Week of Apr 6, 2026

Apr 9, 2026approval91d 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, 2026approval91d agoVABYSMO (FARICIMAB-SVOA) — FDA approvalfaricimab

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

full page →faricimab →fda approvals ↗

Apr 9, 2026approval91d agoFOSFOMYCIN TROMETHAMINE — FDA approvalFOSFOMYCIN TROMETHAMINE

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

full page →FOSFOMYCIN TROMETHAMINE →fda approvals ↗

Apr 9, 2026approval91d agoDILTIAZEM HYDROCHLORIDE — FDA approvalBausch Health US LLC

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

full page →fda approvals ↗

Apr 9, 2026approval91d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

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

full page →fda approvals ↗

Apr 9, 2026approval91d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

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

full page →fda approvals ↗

Apr 9, 2026approval91d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

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

full page →fda approvals ↗

Apr 9, 2026approval91d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

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

full page →fda approvals ↗

Apr 9, 2026approval91d agoDEFLAZACORT — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Apr 9, 2026approval91d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

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

full page →duloxetine hydrochloride DR →fda approvals ↗

Apr 9, 2026approval91d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 9, 2026approval91d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 9, 2026approval91d agoMESNA — FDA approvalMESNA

Sponsor: RISING. Form: INJECTABLE. Route: INTRAVENOUS

full page →MESNA →fda approvals ↗

Apr 9, 2026approval91d agoONUREG (AZACITIDINE) — FDA approvalBristol-Myers Squibb Co

Sponsor: BRISTOL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 9, 2026approval91d agoLEVETIRACETAM — FDA approvalAprecia Pharmaceuticals LLC

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

full page →fda approvals ↗

Apr 9, 2026approval91d agoCOSOPT PF (DORZOLAMIDE HYDROCHLORIDE) — FDA approvalCosopt

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

full page →Cosopt →fda approvals ↗

Apr 9, 2026approval91d agoLAMOTRIGINE — FDA approvalTorrent Pharma Inc

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

full page →fda approvals ↗

Apr 9, 2026approval91d agoREZENOPY (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

Sponsor: SCIENTURE. Form: SPRAY. Route: NASAL

full page →naloxone hydrochloride →fda approvals ↗

Apr 9, 2026approval91d 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, 2026approval91d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Apr 9, 2026approval91d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Apr 9, 2026approval91d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Apr 9, 2026approval91d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Apr 9, 2026device 510k91d agoRay Co., Ltd. — RCT800 (510k cleared)Ray Therapeutics Inc

Product code: OAS. Advisory committee: Radiology. Type: Special

full page →fda device 510k ↗

Apr 9, 2026device 510k91d agoCheckcells, Inc. — Seaman Pro/Seaman (510k cleared)

Product code: POV. Advisory committee: Hematology. Type: Traditional

full page →fda device 510k ↗

Apr 9, 2026device 510k91d agoInternational Life Sciences — Artelon Convenience Kits (510k cleared)

Product code: QWJ. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Apr 9, 2026device 510k91d agoZest Anchors, LLC — LOCATOR® Angled Abutment (510k cleared)

Product code: NHA. Advisory committee: Dental. Type: Special

full page →fda device 510k ↗

Apr 9, 2026device 510k91d agoCG Bio Co., Ltd. — EASYMADE-TI (510k cleared)3H Bio Co Ltd

Product code: GXN. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Apr 9, 2026device 510k91d agoMaduro Medical, Inc. — Radical 6F Access Catheter (510k cleared)

Product code: QJP. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗

Apr 9, 2026device 510k91d agoKLISBio S.r.l. — SILKBridge (510k cleared)

Product code: JXI. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Apr 9, 2026device 510k91d agoSpineart SA — SPINEART Navigation Instrument System (510k cleared)

Product code: OLO. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗

Apr 9, 2026device 510k91d agoShanghai Apolo Medical Technology Co., Ltd. — Picosecond Nd:YAG Laser Systems (Model: HS-298) (510k cleared)NewBay Medical Technology Co Ltd

Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Apr 9, 2026device 510k91d agoAnhui Happiness Workshop Instruments Co., Ltd. — Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) (510k cleared)

Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗

Apr 9, 2026device 510k91d agoShandong Huge Dental Material Corporation — Eternal Art Porcelain Powders (510k cleared)

Product code: EIH. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Apr 9, 2026device 510k91d agoRivanna Medical, Inc. — Accuro XV (510k cleared)Vivani Medical, Inc.

Product code: IYO. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026approval90d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Apr 10, 2026approval90d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

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

full page →LOSARTAN POTASSIUM →fda approvals ↗

Apr 10, 2026approval90d agoMETHYLPREDNISOLONE — FDA approvalPFIZER INC

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

full page →fda approvals ↗