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Week of Oct 20, 2025

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Oct 21, 2025approval314d agoTRIAMTERENE AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalChartwell Pharmaceuticals LLC

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

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Oct 21, 2025approval314d agoTRIAMTERENE AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalChartwell Pharmaceuticals LLC

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

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Oct 21, 2025approval314d agoCALCIUM CHLORIDE 10% (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

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Oct 21, 2025approval314d agoMIEBO (PERFLUOROHEXYLOCTANE) — FDA approvalBausch & Lomb Corp

Sponsor: BAUSCH AND LOMB INC. Form: SOLUTION/DROPS. Route: OPHTHALMIC

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Oct 21, 2025approval314d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

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Oct 21, 2025approval314d agoSUMATRIPTAN SUCCINATE — FDA approvalTonix Pharmaceuticals Holding Corp.

Sponsor: PH HEALTH. Form: INJECTABLE. Route: SUBCUTANEOUS

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Oct 21, 2025approval314d agoSTIMUFEND (PEGFILGRASTIM-FPGK) — FDA approvalSTIMUFEND

Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: INJECTION

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Oct 21, 2025approval314d agoDEFERASIROX — FDA approvalDEFERASIROX

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL

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Oct 21, 2025approval314d agoDEFERASIROX — FDA approvalDEFERASIROX

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL

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Oct 21, 2025approval314d agoDEFERASIROX — FDA approvalDEFERASIROX

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL

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Oct 21, 2025approval314d agoDEFERASIROX — FDA approvalDEFERASIROX

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL

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Oct 21, 2025approval314d agoDEFERASIROX — FDA approvalDEFERASIROX

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL

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Oct 21, 2025approval314d agoDEFERASIROX — FDA approvalDEFERASIROX

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL

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Oct 21, 2025device 510k314d agoOlympus Medical Systems Corporation — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) (510k cleared)

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

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Oct 21, 2025device 510k314d agoMIPM Mammendorfer Institut für Physik und Medizin GmbH — Neuromuscular Transmission Monitor TOF3D (2510091) (510k cleared)

Product code: KOI. Advisory committee: Anesthesiology. Type: Traditional

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Oct 21, 2025device 510k314d agoAstura Medical — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (510k cleared)

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

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Oct 21, 2025device 510k314d agoSimplivia Healthcare , Ltd. — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (510k cleared)

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

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Oct 21, 2025device 510k314d agoMedivis, Inc. — NeuroAlign software (510k cleared)

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

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Oct 21, 2025device 510k314d agoMedos International SARL — TriALTIS Spine System (510k cleared)

Product code: NKB. Advisory committee: Orthopedic. Type: Special

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Oct 21, 2025device 510k314d agoEdwards Lifesciences — HemoSphere Stream Module (510k cleared)Edwards Lifesciences Corp

Product code: DQK. Advisory committee: Cardiovascular. Type: Special

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Oct 21, 2025device 510k314d agoBodycad Laboratories, Inc. — Fine TTO (510k cleared)Barr Laboratories Inc

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

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Oct 21, 2025device 510k314d agoAevumed, Inc. — Aevumed FASE Suture Anchor (510k cleared)

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

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Oct 21, 2025device 510k314d agoCardiocycle Medical(Suzhou) Co., Ltd. — Introducer Sheath Set (510k cleared)

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

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Oct 21, 2025device 510k314d agoLivsmed, Inc. — ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) (510k cleared)

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

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Oct 21, 2025device pma314d agoCordis US Corporation — PRECISE® PRO Rx Nitinol Stent System; PRECISE® PRO Transcarotid Stent System (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30

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Oct 21, 2025device pma314d agoMedtronic Neuromodulation — Altaviva Implantable Neurostimulator (PMA supplement)

Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30

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Oct 21, 2025device pma314d agoBiotronik, Inc. — Astron Peripheral Self- Expanding Nitinol Stent System (PMA supplement)

Supplement type: Special (Immediate Track). Product code: NIO. Advisory committee: CV. Decision: APPR

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Oct 21, 2025device pma314d agoBiotronik, Inc. — Pulsar-18 T3 Stent System (PMA supplement)

Supplement type: Special (Immediate Track). Product code: NIP. Advisory committee: CV. Decision: APPR

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Oct 21, 2025device pma314d agoInspire Medical Systems — Inspire Upper Airway Stimulation (PMA supplement)Inspire Medical Systems, Inc.

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

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Oct 21, 2025device recall314d agoAccriva Diagnostics, Inc. device recall (Cls III)Co-Diagnostics, Inc.

VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. — Reason: Due to an device without a premarket clearance being incorrectly package and distributed. — Status: Ongoing

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Oct 21, 2025device recall314d agoMedtronic MiniMed, Inc. device recall (Cls II)Medtronic USA Inc

CareLink Clinic, REF: MMT-7350 — Reason: Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia. — Status: Ongoing

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Oct 22, 2025approval313d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

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Oct 22, 2025approval313d agoNICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (NICARDIPINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: CAPLIN. Form: INJECTABLE. Route: INTRAVENOUS

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Oct 22, 2025approval313d agoESMOLOL HYDROCHLORIDE — FDA approvalESMOLOL HYDROCHLORIDE

Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION

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Oct 22, 2025approval313d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: L PERRIGO CO. Form: TABLET. Route: ORAL

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Oct 22, 2025approval313d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: L PERRIGO CO. Form: TABLET. Route: ORAL

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Oct 22, 2025approval313d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: L PERRIGO CO. Form: TABLET. Route: ORAL

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Oct 22, 2025approval313d agoOXALIPLATIN — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: NOVAST LABS. Form: INJECTABLE. Route: INTRAVENOUS

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Oct 22, 2025approval313d agoCONTEPO (FOSFOMYCIN DISODIUM) — FDA approvalfosfomycin disodium

Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS

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Oct 22, 2025approval313d agoVYEPTI (EPTINEZUMAB-JJMR) — FDA approvalH. Lundbeck AS

Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION

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Oct 22, 2025approval313d agoVISINE (NAPHAZOLINE HYDROCHLORIDE) — FDA approval

Sponsor: KENVUE BRANDS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

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Oct 22, 2025approval313d agoLOFEXIDINE HYDROCHLORIDE — FDA approvalLOFEXIDINE HYDROCHLORIDE

Sponsor: NOVITIUM PHARMA. Form: TABLET. Route: ORAL

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Oct 22, 2025approval313d agoARIPIPRAZOLE — FDA approvalaripiprazole LA

Sponsor: QUAGEN. Form: SOLUTION. Route: ORAL

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Oct 22, 2025recall313d agoAscend Laboratories, LLC recall (Cls II)Ascend Laboratories Ltd

Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 — Reason: Failed Dissolution Specifications — Status: Ongoing

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Oct 22, 2025recall313d agoRising Pharma Holding, Inc. recall (Cls II)CHINA PHARMA HOLDINGS, INC.

Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01 — Reason: Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg). — Status: Ongoing

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Oct 22, 2025recall313d agoVIONA PHARMACEUTICALS INC recall (Cls II)IONIS PHARMACEUTICALS INC

Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04. — Reason: Discoloration — Status: Ongoing

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Oct 22, 2025recall313d agoSTAQ Pharma, Inc. recall (Cls III)Silo Pharma, Inc.

Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02. — Reason: Labeling: Incorrect or Missing Lot and/or Exp Date — Status: Ongoing

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Oct 22, 2025recall313d agoAscend Laboratories, LLC recall (Cls II)Ascend Laboratories Ltd

Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. — Reason: Failed Dissolution Specifications — Status: Ongoing

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Oct 22, 2025recall313d agoAmerisource Health Services LLC recall (Cls II)AltrixBio Inc

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose] — Reason: CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. — Status: Ongoing

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Oct 22, 2025recall313d agoASTRAZENECA PHARMACEUTICALS recall (Cls II)ASTRAZENECA PLC

Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30 — Reason: Lack of Assurance of Sterility: — Status: Ongoing

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