FDA Novel Drug Approvals – May 2024

Jun 032024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Imdelltra tarlatamab-dlle 5/16/2024 To treat extensive stage small cell

FDA Drug Safety Information for May 31, 2024

May 312024
 

Date Brand Name(s) Description Type Reason Company  5/31/2024 Medline SubG Endotracheal Tubes with Subglottic Suction and kits that contain these devices Medical Devices The inflation

FDA Drug Safety Information for May 10, 2024

May 102024
 

Date Brand Name(s) Description Type Reason Company  5/10/2024 Ethicon Megadyne Mega Soft Pediatric Patient Return Electrode Medical Devices Reports of patient burn injuries Megadyne Medical

FDA Novel Drug Approvals – April 2023

May 012024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Qalsody tofersen 4/25/2023 To treat amyotrophic lateral sclerosis in

FDA Novel Drug Approvals – April 2024

May 012024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Xolremdi mavorixafor 4/26/2024 To treat WHIM syndrome (warts, hypogammaglobulinemia,

FDA Drug Safety Information for April 23, 2024

Apr 232024
 

Date Brand Name(s) Description Type Reason Company  4/23/2024 Schwinnng Herbal Dietary Supplement Drugs Product is tainted with Nortadalafil STOP CLOPEZ CORP 4/23/2024 Dr. Reddy’s Sapropterin

FDA Drug Safety Information for April 8, 2024

Apr 082024
 

Date Brand Name(s) Description Type Reason Company  4/8/2024 Medline and Centurion Convenience kits Medical Devices The potential for a lack of sterility Medline Industries, LP

FDA Drug Safety Information for April 5, 2024

Apr 052024
 

Date Brand Name(s) Description Type Reason Company  4/5/2024 Fendall 2000 Non-Sterile Eyewash Cartridge Drugs Non-compliance with current good manufacturing practice (cGMP) requirements. Honeywell Safety Products

FDA Novel Drug Approvals – March 2024

Apr 012024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Voydeya danicopan 3/29/2024 To treat extravascular hemolysis with paroxysmal nocturnal

FDA Drug Safety Information for April 1, 2024

Apr 012024
 

Date Brand Name(s) Description Type Reason Company  4/1/2024 AVpak Atovaquone Oral Suspension, USP 750mg/5mL Drugs Potential Bacillus cereus contamination AvKARE, LLC

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