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Week of Mar 10, 2025

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Mar 11, 2025device 510k520d agoStryker Instruments — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R (510k cleared)

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

full page →fda device 510k ↗

Mar 11, 2025device 510k520d agoDeka Research & Development Corp. — RemunityPRO Pump for Remodulin® (treprostinil) Injection (510k cleared)UNITED THERAPEUTICS Corp

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

full page →fda device 510k ↗

Mar 11, 2025device 510k520d agoArthrex, Inc. — Arthrex TightRope Soft Button, RT (510k cleared)

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

full page →fda device 510k ↗

Mar 11, 2025device 510k520d agoDisa Medinotec — OutFlo Aortic Valve Dilatation Balloon Catheter (510k cleared)

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

full page →fda device 510k ↗

Mar 11, 2025device 510k520d agoBetter Diagnostics AI Corp. — Better Diagnostics Caries Assist (BDCA) Version 1.0 (510k cleared)CS DIAGNOSTICS CORP.

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

full page →fda device 510k ↗

Mar 11, 2025device 510k520d agoSignature Orthopaedics Pty, Ltd. — Origin TT Stem (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2025approval519d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 12, 2025approval519d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 12, 2025approval519d agoQUDEXY XR (TOPIRAMATE) — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Mar 12, 2025approval519d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Mar 12, 2025approval519d agoTOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Mar 12, 2025approval519d agoEPRONTIA (TOPIRAMATE) — FDA approvaltopiramate ER

Sponsor: AZURITY. Form: SOLUTION. Route: ORAL

full page →topiramate ER →fda approvals ↗

Mar 12, 2025approval519d agoBRAFTOVI (ENCORAFENIB) — FDA approvalencorafenib

Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL

full page →encorafenib →fda approvals ↗

Mar 12, 2025approval519d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 12, 2025approval519d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Mar 12, 2025approval519d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Mar 12, 2025approval519d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →aripiprazole LA →fda approvals ↗

Mar 12, 2025approval519d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION

full page →EPYSQLI →fda approvals ↗

Mar 12, 2025approval519d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

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

full page →ACETAZOLAMIDE →fda approvals ↗

Mar 12, 2025recall519d agoSafecor Health, LLC recall (Cls II)Validus Pharmaceuticals LLC

Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing

full page →fda recalls ↗

Mar 12, 2025recall519d agoSafecor Health, LLC recall (Cls II)Almatica Pharma LLC

Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing

full page →fda recalls ↗

Mar 12, 2025recall519d agoSafecor Health, LLC recall (Cls II)Sri Devaraj Urs Academy of Higher Education and Research

Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing

full page →fda recalls ↗

Mar 12, 2025recall519d agoSUN PHARMACEUTICAL INDUSTRIES INC recall (Cls II)TEVA PHARMACEUTICAL INDUSTRIES LTD

Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01 — Reason: Failed Dissolution Specifications — Status: Ongoing

full page →fda recalls ↗

Mar 12, 2025recall519d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing

full page →fda recalls ↗

Mar 12, 2025recall519d agoSafecor Health, LLC recall (Cls II)Teva Pharmaceuticals USA Inc

Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing

full page →fda recalls ↗

Mar 12, 2025recall519d agoSafecor Health, LLC recall (Cls II)

Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing

full page →fda recalls ↗

Mar 12, 2025recall519d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing

full page →fda recalls ↗

Mar 12, 2025device 510k519d agoRewalk Robotics Ltd. Dba Lifeward — ReWalk® 7 Personal Exoskeleton (50-20-0005) (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2025device 510k519d agoCutting Edge Spine, LLC — EVOL® ha Hyper C Cervical Interbody Fusion System (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2025device 510k519d agoShenzhen Zuowei Technology Co., Ltd. — Walking rehabilitation training electric wheelchair (ZW518) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗

Mar 12, 2025device 510k519d agoQuantalx Neroscience — Delphi Amplifier (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2025device 510k519d agoChangsha Anxiang Medical Technology Co., Ltd. — Wireless TENS & EMS Unit (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2025device 510k519d agoRay Co., Ltd. — RCT600 (510k cleared)Ray Therapeutics Inc

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

full page →fda device 510k ↗

Mar 12, 2025device 510k519d agoRayence Co., Ltd. — 2430TCA with Xmaru W (510k cleared)

Product code: MUE. Advisory committee: Radiology. Type: Special

full page →fda device 510k ↗

Mar 12, 2025device 510k519d agoWontech Co., Ltd. — PICOALEX (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2025device 510k519d agoDannik, LLC — DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2025device 510k519d agoBiofire Defense, LLC — BioFire Warrior Panel; BioFire Warrior Panel Control Kit (510k cleared)Dawn Sea Therapeutics

Product code: PRD. Advisory committee: Immunology. Type: Traditional

full page →fda device 510k ↗

Mar 13, 2025approval518d agoMILNACIPRAN HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Mar 13, 2025approval518d agoMILNACIPRAN HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Mar 13, 2025approval518d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

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

full page →ACETAZOLAMIDE →fda approvals ↗

Mar 13, 2025approval518d agoARBLI (LOSARTAN POTASSIUM) — FDA approvalLOSARTAN POTASSIUM

Sponsor: SCIENTURE. Form: SUSPENSION. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗

Mar 13, 2025approval518d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS

full page →TYENNE →fda approvals ↗

Mar 13, 2025approval518d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Mar 13, 2025approval518d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Mar 13, 2025approval518d agoMEROPENEM — FDA approvalHQ Speciality Pharma

Sponsor: BROOKS STERISCIENCE. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 13, 2025approval518d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →PYZCHIVA →fda approvals ↗

Mar 13, 2025approval518d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →PYZCHIVA →fda approvals ↗

Mar 13, 2025approval518d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Mar 13, 2025approval518d agoBUCAPSOL (BUSPIRONE HYDROCHLORIDE) — FDA approvalBUSPIRONE HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC. Form: CAPSULE. Route: ORAL

full page →BUSPIRONE HYDROCHLORIDE →fda approvals ↗

Mar 13, 2025device 510k518d agoBioserenity Medical Devices Group — IceCap product line (510k cleared)

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

full page →fda device 510k ↗

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