FDA Drug Safety Information for November 19, 2024

Nov 192024
 

Date Brand Name(s) Description Type Reason Company  11/19/2024 Par Pharmaceutical Clonazepam Orally Disintegrating Tablets, USP (C-IV) Drugs Mislabeled with the incorrect strength on the carton

FDA Novel Drug Approvals – October 2024

Nov 012024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Orlynvah sulopenem etzadroxil, probenecid 10/25/2024 To treat uncomplicated urinary

FDA Drug Safety Information for October 16, 2024

Oct 162024
 

Date Brand Name(s) Description Type Reason Company  10/16/2024 STASKA Pharmaceuticals Ascorbic Acid Solution for Injection Drugs Device & Drug Safety – Presence of glass particulates

FDA Drug Safety Information for October 7, 2024

Oct 072024
 

Date Brand Name(s) Description Type Reason Company  10/7/2024 Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators Medical Devices The

FDA Novel Drug Approvals – September 2024

Oct 012024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Flyrcado flurpiridaz F 18 9/27/2024 A radioactive diagnostic drug to evaluate

FDA Drug Safety Information for September 18, 2024

Sep 182024
 

Date Brand Name(s) Description Type Reason Company  9/18/2024 BionPharma Atovaquone Oral Suspension, 750 mg/mL Drugs Product found to be contaminated with Cohnella bacteria Bionpharma Inc.

FDA Drug Safety Information for September 4, 2024

Sep 042024
 

Date Brand Name(s) Description Type Reason Company  9/4/2024 Bivona Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™

FDA Novel Drug Approvals – August 2024

Sep 012024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Lazcluze lazertinib 8/19/2024 To treat non-small cell lung cancer

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