Calendar

Week of Nov 3, 2025

Nov 4, 2025device pma298d agoQ-Med AB — Restylane® Lyft with Lidocaine (PMA supplement)Sustained Therapeutics Inc

Supplement type: Panel Track. Product code: LMH. Advisory committee: SU. Decision: APPR

Nov 4, 2025device pma298d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, (PMA supplement)

Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Nov 4, 2025device pma298d agoMedtronic Neuromodulation — nterStim Therapy System, Verify Evaluation System (PMA supplement)

Supplement type: Real-Time Process. Product code: QON. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗

Nov 4, 2025device pma298d agoMedtronic Neuromodulation — InterStim Therapy System, Verify Evaluation System (PMA supplement)

Supplement type: Real-Time Process. Product code: EZW. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗

Nov 4, 2025device pma298d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (LVAS) (PMA supplement)

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

full page →fda device pma ↗

Nov 4, 2025device pma298d agoETHICON, Inc. — SURGICEL® Absorbable Hemostats (PMA supplement)

Supplement type: Real-Time Process. Product code: LMG. Advisory committee: SU. Decision: APPR

full page →fda device pma ↗

Nov 4, 2025device pma298d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

Supplement type: Real-Time Process. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Nov 4, 2025device recall298d agoDatascope Corp. device recall (Cls II)

Cardiosave Rescue. Intra-Aortic Balloon Pump system. — Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. — Status: Ongoing

full page →fda device recalls ↗

Nov 4, 2025device recall298d agoDatascope Corp. device recall (Cls II)

Cardiosave Hybrid. Intra-Aortic Balloon Pump system. — Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. — Status: Ongoing

full page →fda device recalls ↗

Nov 5, 2025approval297d agoBOSENTAN — FDA approvalBOSENTAN

Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL

full page →BOSENTAN →fda approvals ↗

Nov 5, 2025approval297d agoBOSENTAN — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

Nov 5, 2025approval297d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: SUN PHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Nov 5, 2025approval297d agoBOSENTAN — FDA approvalBOSENTAN

Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →BOSENTAN →fda approvals ↗

Nov 5, 2025approval297d agoBOSENTAN — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Nov 5, 2025approval297d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: PH HEALTH. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Nov 5, 2025approval297d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Nov 5, 2025approval297d agoBOSENTAN — FDA approvalBOSENTAN

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

full page →BOSENTAN →fda approvals ↗

Nov 5, 2025approval297d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Nov 5, 2025approval297d agoLACTATED RINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

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

full page →CALCIUM CHLORIDE 10% →fda approvals ↗

Nov 5, 2025approval297d agoDEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalBaxter Healthcare Corp

Sponsor: B BRAUN. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Nov 5, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: CADILA PHARMS LTD. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 5, 2025approval297d agoLACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

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

full page →CALCIUM CHLORIDE 10% →fda approvals ↗

Nov 5, 2025approval297d agoRINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: B BRAUN. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Nov 5, 2025approval297d agoWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

Sponsor: BAUSCH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Nov 5, 2025approval297d agoCONTRAVE (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

Sponsor: NALPROPION. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Nov 5, 2025approval297d agoCONTRAVE (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

Sponsor: NALPROPION. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Nov 5, 2025approval297d agoMACITENTAN — FDA approvalJOHNSON & JOHNSON

Sponsor: LAURUS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Nov 5, 2025approval297d agoPOTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

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

full page →CALCIUM CHLORIDE 10% →fda approvals ↗

Nov 5, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Nov 5, 2025approval297d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: GLAXOSMITHKLINE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 5, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 5, 2025approval297d agoSODIUM OXYBATE — FDA approval(calcium oxybate + magnesium oxybate + potassium oxybate + sodium oxybate)

Sponsor: ASCENT PHARMS INC. Form: SOLUTION. Route: ORAL

full page →(calcium oxybate + magnesium oxybate + potassium oxybate + sodium oxybate) →fda approvals ↗

Nov 5, 2025approval297d agoCAPLYTA (LUMATEPERONE TOSYLATE) — FDA approvallumateperone tosylate

Sponsor: INTRA-CELLULAR. Form: CAPSULE. Route: ORAL

full page →lumateperone tosylate →fda approvals ↗

Nov 5, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 5, 2025approval297d agoAUVELITY (BUPROPION HYDROCHLORIDE) — FDA approval(bupropion hydrochloride + dextromethorphan) ER

Sponsor: AXSOME. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →(bupropion hydrochloride + dextromethorphan) ER →fda approvals ↗

Nov 5, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 5, 2025approval297d agoFORFIVO XL (BUPROPION HYDROCHLORIDE) — FDA approvalTWi Pharmaceuticals Inc

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

full page →fda approvals ↗

Nov 5, 2025approval297d agoDICLOFENAC SODIUM — FDA approvalHisamitsu Pharmaceutical Co Inc

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

full page →fda approvals ↗

Nov 5, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: JUBILANT GENERICS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 5, 2025approval297d agoAPLENZIN (BUPROPION HYDROBROMIDE) — FDA approvalBausch Health US LLC

Sponsor: BAUSCH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Nov 5, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 5, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 5, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 5, 2025approval297d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 5, 2025approval297d agoLACTATED RINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalBaxter Healthcare Corp

Sponsor: B BRAUN. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Nov 5, 2025approval297d agoUNASYN (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Nov 5, 2025recall297d agoProRx LLC recall (Cls II)Novo Nordisk AS

Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Nov 5, 2025recall297d agoProRx LLC recall (Cls II)Novo Nordisk AS

Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Nov 5, 2025recall297d agoFARMAKEIO OUTSOURCING LLC recall (Cls II)Sun Pharmaceutical Industries Ltd

Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01 — Reason: CGMP Deviations: Potential presence of metal particulate matter — Status: Ongoing

full page →fda recalls ↗

Nov 5, 2025recall297d agoTeva Pharmaceuticals USA, Inc recall (Cls II)Terns Pharmaceuticals, Inc.

Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10 — Reason: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. — Status: Ongoing

full page →fda recalls ↗

← prev

page 4 of 266

Week of Nov 3, 2025