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Week of Jan 26, 2026

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Jan 30, 2026approval193d agoZYPREXA ZYDIS (OLANZAPINE) — FDA approvalDR REDDYS LABORATORIES LTD

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

full page →fda approvals ↗

Jan 30, 2026approval193d agoBRIVARACETAM — FDA approvalUCB SA

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 30, 2026approval193d agoBRIVARACETAM — FDA approvalUCB SA

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

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Jan 30, 2026approval193d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

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Jan 30, 2026approval193d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Jan 30, 2026approval193d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

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Jan 30, 2026approval193d agoARSENIC TRIOXIDE — FDA approvalQuetzal Therapeutics LLC

Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INJECTION

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Jan 30, 2026approval193d agoEPIRUBICIN HYDROCHLORIDE — FDA approvalEPIRUBICIN HYDROCHLORIDE

Sponsor: CIPLA LTD. Form: INJECTABLE. Route: INJECTION

full page →EPIRUBICIN HYDROCHLORIDE →fda approvals ↗

Jan 30, 2026approval193d agoAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN) — FDA approvalHikma Pharmaceuticals Plc

Sponsor: HIKMA PHARMS. Form: FOR SUSPENSION. Route: ORAL

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Jan 30, 2026approval193d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

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Jan 30, 2026approval193d agoLIVDELZI (SELADELPAR LYSINE) — FDA approvalseladelpar lysine

Sponsor: GILEAD SCIENCES INC. Form: CAPSULE. Route: ORAL

full page →seladelpar lysine →fda approvals ↗

Jan 30, 2026approval193d agoLATANOPROST — FDA approvalXalatan

Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Xalatan →fda approvals ↗

Jan 30, 2026approval193d agoLATANOPROST — FDA approvalXalatan

Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Xalatan →fda approvals ↗

Jan 30, 2026approval193d agoLATANOPROST — FDA approvalXalatan

Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Xalatan →fda approvals ↗

Jan 30, 2026approval193d agoEMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE (EMTRICITABINE) — FDA approvalemtricitabine

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →emtricitabine →fda approvals ↗

Jan 30, 2026approval193d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR

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Jan 30, 2026approval193d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Jan 30, 2026approval193d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Jan 30, 2026approval193d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Jan 30, 2026approval193d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Jan 30, 2026approval193d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Jan 30, 2026approval193d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 30, 2026approval193d agoLYBALVI (OLANZAPINE) — FDA approval(olanzapine + samidorphan l-malate)

Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL

full page →(olanzapine + samidorphan l-malate) →fda approvals ↗

Jan 30, 2026approval193d agoVENLAFAXINE HYDROCHLORIDE — FDA approvalViatris Inc

Sponsor: PLATINUM. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

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Jan 30, 2026approval193d agoCETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE) — FDA approvalCETIRIZINE HYDROCHLORIDE

Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

full page →CETIRIZINE HYDROCHLORIDE →fda approvals ↗

Jan 30, 2026approval193d agoDAPTOMYCIN — FDA approvalDaptomycin Novo

Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS

full page →Daptomycin Novo →fda approvals ↗

Jan 30, 2026approval193d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

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Jan 30, 2026approval193d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL

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Jan 30, 2026approval193d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

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Jan 30, 2026approval193d agoVALACYCLOVIR HYDROCHLORIDE — FDA approvalVALACYCLOVIR HYDROCHLORIDE

Sponsor: JUBILANT GENERICS. Form: TABLET. Route: ORAL

full page →VALACYCLOVIR HYDROCHLORIDE →fda approvals ↗

Jan 30, 2026device 510k193d agoHangzhou Clongene Biotech Co., Ltd. — Clungene RSV Antigen Rapid Test (510k cleared)Hangzhou DAC Biotech Co Ltd

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

full page →fda device 510k ↗

Jan 30, 2026device 510k193d agoShenzhen Peninsula Medical Group — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) (510k cleared)

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

full page →fda device 510k ↗

Jan 30, 2026device 510k193d agoSaeshin Precision Co., Ltd. — Motor Handpiece and Control Unit (SDI10) (510k cleared)

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

full page →fda device 510k ↗

Jan 30, 2026device 510k193d agoShanghai SeeGen Photoelectric Technology Co., Ltd. — Disposable Distal End Tape Hood (510k cleared)

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

full page →fda device 510k ↗

Jan 30, 2026device 510k193d agoParagonix Technologies, Inc. — BAROguard Donor Lung Preservation System (510k cleared)POET TECHNOLOGIES INC.

Product code: KDN. Advisory committee: Gastroenterology, Urology. Type: Special

full page →fda device 510k ↗

Jan 30, 2026device 510k193d agoPrecision Medical Ventures, Inc. Dba Revealdx — RevealAI-Lung (510k cleared)

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

full page →fda device 510k ↗

Jan 30, 2026device 510k193d agoShenzhen Jianchao Intelligent Technology Co., Ltd. — Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) (510k cleared)

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

full page →fda device 510k ↗

Jan 30, 2026device 510k193d agoPrismatik Dentalcraft, Inc. — BruxZir® Shaded 16 PLUS (510k cleared)

Product code: EIH. Advisory committee: Dental. Type: Special

full page →fda device 510k ↗

Jan 30, 2026device 510k193d agoBoston Aesthetics, Inc. — Boston PICO (Boston PICO) (510k cleared)

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

full page →fda device 510k ↗

Jan 30, 2026device 510k193d agoSorin Group Italia S.R.L. — Dual Stage Venous Cannulae (510k cleared)

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

full page →fda device 510k ↗

Jan 30, 2026device 510k193d agoAsistan Medikal — Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) (510k cleared)

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

full page →fda device 510k ↗

Jan 30, 2026device pma193d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

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

full page →fda device pma ↗

Jan 30, 2026device pma193d agoBoston Scientific Corp — Eluvia Drug-Eluting Vascular Stent System (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Jan 30, 2026device pma193d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Jan 30, 2026device pma193d agoInspire Medical Systems — QMR Battery Separator Supplier (PMA supplement)Inspire Medical Systems, Inc.

Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30

full page →fda device pma ↗

Jan 30, 2026device pma193d agoBalt USA, LLC — SQUID Liquid Embolic Agent (LEA) (PMA)Bayer USA LLC

Product code: SGU. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Jan 30, 2026device pma193d agoMedtronic Vascular, Inc. — IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (PMA supplement)DFB Soria LLC

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

full page →fda device pma ↗

Jan 30, 2026device recall193d agoBeckman Coulter Mishima K.K. device recall (Cls II)

CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 — Reason: A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment — Status: Ongoing

full page →fda device recalls ↗

Jan 30, 2026device recall193d agoMedline Industries, LP device recall (Cls II)CARDINAL HEALTH INC

Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851 — Reason: The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older. — Status: Ongoing

full page →fda device recalls ↗

Jan 30, 2026device recall193d agoBeckman Coulter Mishima K.K. device recall (Cls II)

DxC 700 AU, REF: B86444, B86446 — Reason: A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment. — Status: Ongoing

full page →fda device recalls ↗

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