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

FDA Drug Safety Information for March 28, 2024

Mar 282024
 

Date Brand Name(s) Description Type Reason Company  3/28/2024 Eugia US LLC Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) Drugs Device & Drug

FDA Drug Safety Information for March 27, 2024

Mar 272024
 

Date Brand Name(s) Description Type Reason Company  3/27/2024 Amneal Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL Drugs Super potent due to bottles being overfilled

FDA Drug Safety Information for March 20, 2024

Mar 202024
 

Date Brand Name(s) Description Type Reason Company  3/20/2024 Nimbus Nimbus Pump System Medical Devices Recall due to a high number (3698) of customer complaints related

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