Calendar

pharmadog

Week of Nov 10, 2025

Nov 13, 2025approval290d agoBRIVARACETAM — FDA approvalBRIVARACETAM

Sponsor: MSN. Form: TABLET. Route: ORAL

full page →BRIVARACETAM →fda approvals ↗

Nov 13, 2025approval290d agoPOHERDY (PERTUZUMAB-DPZB) — FDA approvalpertuzumab biosimilar

Sponsor: SHANGHAI HENLIUS BIOTECH. Form: INJECTABLE. Route: INTRAVENOUS

full page →pertuzumab biosimilar →fda approvals ↗

Nov 13, 2025approval290d agoLEUPROLIDE ACETATE — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Nov 13, 2025approval290d agoONDANSETRON — FDA approvalSandoz Inc

Sponsor: BARR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

Nov 13, 2025approval290d agoRALDESY (TRAZODONE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KAMAT. Form: SOLUTION. Route: ORAL

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Nov 13, 2025approval290d agoIOHEXOL — FDA approvalIOHEXOL

Sponsor: AMNEAL. Form: SOLUTION. Route: INJECTION, ORAL, RECTAL

full page →IOHEXOL →fda approvals ↗

Nov 13, 2025device 510k290d agoOrthosoft Inc. (d/b/a) Zimmer CAS — Rosa® Knee System (510k cleared)

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

full page →fda device 510k ↗

Nov 13, 2025device 510k290d agoFussen Technology Co., Ltd. — Dental Computed Tomography X-ray System (510k cleared)Viomi Technology Co., Ltd

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

full page →fda device 510k ↗

Nov 13, 2025device 510k290d agoAtop Lighting Co., Ltd. — LED Beauty Mask (RLBXX) (510k cleared)

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

full page →fda device 510k ↗

Nov 13, 2025device 510k290d agoTelltale, LLC — TELLTALE Electrosurgical Guidewire System (510k cleared)

Product code: SGO. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Nov 13, 2025device 510k290d agoShenzhen Future Electronic Co., Ltd. — Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) (510k cleared)

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

full page →fda device 510k ↗

Nov 13, 2025device 510k290d agoSiemens Medical Solutions USA, Inc. — ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System (510k cleared)

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

full page →fda device 510k ↗

Nov 13, 2025device 510k290d agoSkeletal Dynamics, Inc. — Geminus Volar Distal Radius Plating System (510k cleared)

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

full page →fda device 510k ↗

Nov 13, 2025device pma290d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

Supplement type: Normal 180 Day Track. Product code: MHY. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Nov 13, 2025device pma290d agoMedtronic, Inc. — SynchroMed Infusion System, Ascenda Intrathecal Catheters (PMA supplement)Medtronic plc

Supplement type: Normal 180 Day Track. Product code: LKK. Advisory committee: HO. Decision: APPR

full page →fda device pma ↗

Nov 13, 2025device pma290d agoBaxter Healthcare Corp — Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (PMA supplement)Baxter Healthcare Corp

Supplement type: 30-Day Notice. Product code: PMX. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Nov 13, 2025device pma290d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Nov 13, 2025device recall290d agoAbbott Laboratories device recall (Cls II)ABBOTT LABORATORIES

Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 — Reason: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations. — Status: Ongoing

full page →fda device recalls ↗

Nov 13, 2025device recall290d agoMicrobiologics Inc device recall (Cls II)FibroBiologics, Inc.

KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K — Reason: Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. — Status: Ongoing

full page →fda device recalls ↗

Nov 13, 2025device recall290d agoMedtronic MiniMed, Inc. device recall (Cls II)Medtronic USA Inc

InPen App, Model/CFN Number: MMT-8061 (Android Users) — Reason: When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia. — Status: Ongoing

full page →fda device recalls ↗

Nov 13, 2025device recall290d agoMedline Industries, LP device recall (Cls II)

SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000 — Reason: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized. — Status: Ongoing

full page →fda device recalls ↗

Nov 13, 2025device recall290d agoMedline Industries, LP device recall (Cls II)

FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 — Reason: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized. — Status: Ongoing

full page →fda device recalls ↗

Nov 14, 2025approval289d agoDANZITEN (NILOTINIB TARTRATE) — FDA approvalDANZITEN

Sponsor: AZURITY. Form: TABLET. Route: ORAL

full page →DANZITEN →fda approvals ↗

Nov 14, 2025approval289d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →(daratumumab + hyaluronidase (human recombinant)) →fda approvals ↗

Nov 14, 2025approval289d agoALDACTAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Nov 14, 2025approval289d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

full page →fda approvals ↗

Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

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Nov 14, 2025approval289d agoDIAZEPAM — FDA approvalDIAZEPAM

Sponsor: NAVINTA LLC. Form: GEL. Route: RECTAL

full page →DIAZEPAM →fda approvals ↗

Nov 14, 2025approval289d agoLENALIDOMIDE — FDA approvalLENALIDOMIDE

Sponsor: ACCORD HLTHCARE. Form: CAPSULE. Route: ORAL

full page →LENALIDOMIDE →fda approvals ↗

Nov 14, 2025approval289d agoDIPHENHYDRAMINE HYDROCHLORIDE — FDA approvalPAI Holding Co LLC

Sponsor: AVET LIFESCIENCES. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Nov 14, 2025approval289d agoFOSFOMYCIN TROMETHAMINE — FDA approvalFOSFOMYCIN TROMETHAMINE

Sponsor: AUROBINDO PHARMA LTD. Form: FOR SOLUTION. Route: ORAL

full page →FOSFOMYCIN TROMETHAMINE →fda approvals ↗

Nov 14, 2025approval289d agoALDACTONE (SPIRONOLACTONE) — FDA approvalALDACTONE

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →ALDACTONE →fda approvals ↗

Nov 14, 2025approval289d agoDILTIAZEM HYDROCHLORIDE — FDA approvalDILTIAZEM HYDROCHLORIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →DILTIAZEM HYDROCHLORIDE →fda approvals ↗

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Week of Nov 10, 2025