Calendar

pharmadog

Week of Nov 3, 2025

Nov 4, 2025approval284d agoMEDROL (METHYLPREDNISOLONE) — FDA approvalMEDROL

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →MEDROL →fda approvals ↗

Nov 4, 2025approval284d agoISOFLURANE — FDA approvalSedana Medical AB

Sponsor: SHANDONG. Form: LIQUID. Route: INHALATION

full page →fda approvals ↗

Nov 4, 2025approval284d agoMARAVIROC — FDA approvalForest Hills Partners Hong Kong Ltd

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

full page →fda approvals ↗

Nov 4, 2025approval284d agoDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

Nov 4, 2025approval284d agoIRBESARTAN — FDA approvalIRBESARTAN

Sponsor: MSN. Form: TABLET. Route: ORAL

full page →IRBESARTAN →fda approvals ↗

Nov 4, 2025approval284d agoPHYTONADIONE — FDA approvalPHYTONADIONE

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

full page →PHYTONADIONE →fda approvals ↗

Nov 4, 2025approval284d agoLOPROX (CICLOPIROX) — FDA approvalATLAS Molecular Pharma SL

Sponsor: EUROFARMA. Form: SUSPENSION. Route: TOPICAL

full page →fda approvals ↗

Nov 4, 2025approval284d agoSULFASALAZINE — FDA approvalsulfasalazine DR

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →sulfasalazine DR →fda approvals ↗

Nov 4, 2025approval284d agoISTURISA (OSILODROSTAT PHOSPHATE) — FDA approvalosilodrostat phosphate

Sponsor: RECORDATI RARE. Form: TABLET. Route: ORAL

full page →osilodrostat phosphate →fda approvals ↗

Nov 4, 2025approval284d agoMIRABEGRON — FDA approvalmirabegron ER

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

full page →mirabegron ER →fda approvals ↗

Nov 4, 2025approval284d agoRISPERIDONE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Nov 4, 2025approval284d agoLOPROX (CICLOPIROX) — FDA approvalATLAS Molecular Pharma SL

Sponsor: EUROFARMA. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Nov 4, 2025approval284d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

Sponsor: PHARMACIA AND UPJOHN. Form: INJECTABLE. Route: INJECTION

full page →methylprednisolone sodium succinate →fda approvals ↗

Nov 4, 2025approval284d agoLINZESS (LINACLOTIDE) — FDA approvallinaclotide

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →linaclotide →fda approvals ↗

Nov 4, 2025device 510k284d agoGM Dos Reis Industria e Comercio Ltda. — GMReis Suture Anchors (510k cleared)

Product code: MBI. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Nov 4, 2025device 510k284d agoPrimed Medical Products, Inc. — PRIMED Surgical and Procedure Masks (510k cleared)UTAH MEDICAL PRODUCTS INC

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

full page →fda device 510k ↗

Nov 4, 2025device 510k284d agoKarma Mobility Co, Ltd. — Flexx Junior (FLX-J00, FLX-J50) (510k cleared)

Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗

Nov 4, 2025device 510k284d agoVieworks Co., Ltd. — VXvue (510k cleared)

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

full page →fda device 510k ↗

Nov 4, 2025device 510k284d agoMedcad — MedCAD® AccuStride System (510k cleared)

Product code: PBF. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Nov 4, 2025device 510k284d agoApplied Medical Resources Corp. — Voyant® Open Fusion Device (EB240/Open Fusion) (510k cleared)

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special

full page →fda device 510k ↗

Nov 4, 2025device 510k284d agoMerit Medical Systems, Inc. — Merit Syringe (510k cleared)MERIT MEDICAL SYSTEMS INC

Product code: FMF. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗

Nov 4, 2025device 510k284d agoMenovex Medical Technology (Shenzhen) Co., Ltd. — Tamburo Thulium Fiber Laser System (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗

Nov 4, 2025device 510k284d agoSiemens Medical Solutions USA, Inc. — Cios Select (510k cleared)

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

full page →fda device 510k ↗

Nov 4, 2025device pma284d agoQ-Med AB — Restylane® Lyft with Lidocaine (PMA supplement)Sustained Therapeutics Inc

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

full page →fda device pma ↗

Nov 4, 2025device pma284d 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 pma284d 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 pma284d 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 pma284d 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 pma284d 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 pma284d 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 recall284d 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 recall284d 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, 2025approval283d agoBOSENTAN — FDA approvalBOSENTAN

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

full page →BOSENTAN →fda approvals ↗

Nov 5, 2025approval283d agoBOSENTAN — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

Nov 5, 2025approval283d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

full page →fda approvals ↗

Nov 5, 2025approval283d agoBOSENTAN — FDA approvalBOSENTAN

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

full page →BOSENTAN →fda approvals ↗

Nov 5, 2025approval283d agoBOSENTAN — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Nov 5, 2025approval283d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

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Nov 5, 2025approval283d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET. Route: ORAL

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Nov 5, 2025approval283d agoBOSENTAN — FDA approvalBOSENTAN

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

full page →BOSENTAN →fda approvals ↗

Nov 5, 2025approval283d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

full page →fda approvals ↗

Nov 5, 2025approval283d 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, 2025approval283d 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, 2025approval283d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 5, 2025approval283d 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, 2025approval283d agoRINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Nov 5, 2025approval283d agoWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

full page →fda approvals ↗

Nov 5, 2025approval283d agoCONTRAVE (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

full page →fda approvals ↗

Nov 5, 2025approval283d agoCONTRAVE (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

full page →fda approvals ↗

Nov 5, 2025approval283d agoMACITENTAN — FDA approvalJOHNSON & JOHNSON

Sponsor: LAURUS. Form: TABLET. Route: ORAL

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Week of Nov 3, 2025