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 pma91d agoSynergy Spine Solutions, Inc. — Synergy Disc (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: MJO. Advisory committee: OR. Decision: APPR

full page →fda device pma ↗

Apr 9, 2026device pma91d agoAsahi Kasei Medical Co., Ltd. — Plasmaflo OP-05 W(A) (PMA supplement)

Supplement type: 30-Day Notice. Product code: MDP. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Apr 9, 2026device pma91d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) (PMA supplement)

Supplement type: 30-Day Notice. Product code: QZK. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Apr 9, 2026device pma91d agoMedtronic, Inc. — Avalus Bioprosthesis (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Apr 9, 2026device pma91d agoEv3 Neurovascular — Apollo Onyx Delivery Micro Catheter (PMA supplement)

Supplement type: 30-Day Notice. Product code: MFE. Advisory committee: NE. Decision: OK30

full page →fda device pma ↗

Apr 9, 2026device pma91d agoAdvanced Bionics — HiResolution Bionic Ear System Ultra and Ultra 3D Thin PCB (PMA supplement)

Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30

full page →fda device pma ↗

Apr 9, 2026device pma91d agoNovocure, GmbH — Optune HFE Transducer Array Soft Part Components (PMA supplement)NovoCure Ltd

Supplement type: 30-Day Notice. Product code: NZK. Advisory committee: NE. Decision: OK30

full page →fda device pma ↗

Apr 9, 2026device pma91d agoCooperVision, Inc. — Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity Multifocal; Bio (PMA supplement)

Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

full page →fda device pma ↗

Apr 9, 2026device pma91d agoSeikagaku Corp. — GEL-ONE (PMA supplement)Seikagaku Corp

Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30

full page →fda device pma ↗

Apr 9, 2026device pma91d agoMedtronic, Inc. — Melody Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

Supplement type: 135 Review Track For 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 9, 2026device pma91d agoEdwards Lifesciences, LLC — SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (PMA supplement)Edwards Lifesciences Corp

Supplement type: Real-Time Process. Product code: NPT. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 9, 2026device pma91d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (PMA supplement)Edwards Lifesciences Corp

Supplement type: Real-Time Process. Product code: NPV. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 9, 2026device pma91d agoBoston Scientific Corp — Rotablator; ROTAPRO Rotational Atherectomy Systems (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Apr 9, 2026device pma91d agoABBOTT MEDICAL — FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE) (PMA supplement)

Supplement type: 30-Day Notice. Product code: OAD. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

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 ↗

Apr 10, 2026approval90d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE