Calendar

pharmadog

Week of Oct 6, 2025

Oct 10, 2025approval309d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoUNITUXIN (DINUTUXIMAB) — FDA approvalUNITED THERAPEUTICS Corp

Sponsor: UNITED THERAP. Form: INJECTABLE. Route: INTRAVENOUS

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Oct 10, 2025approval309d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS

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Oct 10, 2025approval309d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS

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Oct 10, 2025approval309d agoGALLIUM GA 68 EDOTREOTIDE (GALLIUM GA-68 EDOTREOTIDE) — FDA approval

Sponsor: METHODIST. Form: SOLUTION. Route: INTRAVENOUS

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Oct 10, 2025approval309d agoRINVOQ LQ (UPADACITINIB) — FDA approvalupadacitinib

Sponsor: ABBVIE. Form: SOLUTION. Route: ORAL

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Oct 10, 2025approval309d agoONGENTYS (OPICAPONE) — FDA approvalopicapone

Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL

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Oct 10, 2025approval309d agoOLPRUVA (SODIUM PHENYLBUTYRATE) — FDA approvalSODIUM PHENYLBUTYRATE

Sponsor: ACER. Form: FOR SUSPENSION. Route: ORAL

full page →SODIUM PHENYLBUTYRATE →fda approvals ↗

Oct 10, 2025approval309d agoCHLORPROMAZINE HYDROCHLORIDE — FDA approvalFosun Pharma USA Inc

Sponsor: RUBICON. Form: CONCENTRATE. Route: ORAL

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Oct 10, 2025approval309d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL

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Oct 10, 2025approval309d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalMicro Labs Ltd

Sponsor: UMEDICA. Form: TABLET. Route: ORAL

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Oct 10, 2025approval309d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

full page →upadacitinib tartrate ER →fda approvals ↗

Oct 10, 2025device 510k309d agoDev4 — Eleganz IM Threaded Nail System (IM Threaded Nail System) (510k cleared)

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

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Oct 10, 2025device 510k309d agoEvoEndo, Inc. — EvoEndo Single-Use Endoscopy System (510k cleared)

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

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Oct 10, 2025device 510k309d agoDegen Medical — DeGen Medical Latitude-C AM Cervical Interbody Fusion System (510k cleared)

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

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Oct 10, 2025device 510k309d agoGold Standard Diagnostics, LLC — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (510k cleared)

Product code: GMQ. Advisory committee: Microbiology. Type: Traditional

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Oct 10, 2025device 510k309d agoOlympus Medical Systems Corporation — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) (510k cleared)

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

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Oct 10, 2025device 510k309d agoSolventum US, LLC — Tegaderm Post-Op Transparent Antimicrobial Dressing (510k cleared)

Product code: FRO. Advisory committee: Unknown. Type: Traditional

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Oct 10, 2025device 510k309d agoTHINK Surgical, Inc. — TMINI Miniature Robotic System (510k cleared)

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

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Oct 10, 2025device 510k309d agoSoclean, Inc. — SoClean 3+ (510k cleared)

Product code: QXQ. Advisory committee: General Hospital. Type: Traditional

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Oct 10, 2025device 510k309d agoACON Laboratories, Inc. — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System (510k cleared)Alcon Laboratories Inc

Product code: NBW. Advisory committee: Clinical Chemistry. Type: Traditional

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Oct 10, 2025device 510k309d agoOsseofuse International, Inc. — HexaPLUS S OneDrill Implant System (510k cleared)ICF International, Inc.

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

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Oct 10, 2025device 510k309d agoZeta Surgical, Inc. — Zeta Navigation System (ZNS131-US) (510k cleared)

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

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Oct 10, 2025device 510k309d agoProcept Biorobotics — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) (510k cleared)PROCEPT BioRobotics Corp

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

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Oct 10, 2025device 510k309d agoWinner Medical Co., Ltd. — Collagen Wound Dressing (510k cleared)

Product code: KGN. Advisory committee: Unknown. Type: Traditional

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Oct 10, 2025device 510k309d agoFoshan Jindi Electric Appliance Co., Ltd. — IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) (510k cleared)

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

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Oct 10, 2025device 510k309d agoCryosurgery, Inc. — Verruca-Freeze H Plus (510k cleared)

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

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Oct 10, 2025device 510k309d agoCanon Medical Systems Corporation — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (510k cleared)

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

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Oct 10, 2025device 510k309d agoNeocis, Inc. — Yomi Robotic System (510k cleared)

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

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Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

full page →fda device pma ↗

Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

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Oct 10, 2025device pma309d agoMedtronic, Inc. — DiamondTemp Ablation System (PMA supplement)Medtronic plc

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

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Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

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Oct 10, 2025device pma309d agoMerz North America, Inc. — Belotero Balance (+) Lidocaine Dermal Filler (PMA supplement)Sustained Therapeutics Inc

Supplement type: Normal 180 Day Track. Product code: LMH. Advisory committee: SU. Decision: APPR

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Oct 10, 2025device pma309d agoEdwards Lifesciences, LLC — SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (PMA supplement)Edwards Lifesciences Corp

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

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Oct 10, 2025device pma309d agoBolton Medical, Inc. — RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (PMA supplement)

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

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Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (PMA supplement)

Supplement type: Real-Time Process. Product code: MYL. Advisory committee: MI. Decision: APPR

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Oct 10, 2025device pma309d agoCentinel Spine, LLC — prodisc C SK and prodisc C Vivo (PMA supplement)

Supplement type: Panel Track. Product code: MJO. Advisory committee: OR. Decision: APPR

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Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® XL Murex Anti-HBc and LIAISON® XL MUREX Control anti-HBc (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

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Oct 10, 2025device pma309d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

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

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Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

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Oct 10, 2025device pma309d agoBiotronik, Inc. — Orsiro Mission Sirolimus Eluting Coronary Stent System (PMA supplement)OrphAI Therapeutics Inc

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

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Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (PMA supplement)

Supplement type: Real-Time Process. Product code: NCD. Advisory committee: MI. Decision: APPR

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Oct 10, 2025device pma309d agoDiaSorin, Inc. — LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

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Week of Oct 6, 2025