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

FDA Drug Safety Information for March 12, 2024

Mar 122024
 

Date Brand Name(s) Description Type Reason Company  3/12/2024 Par Pharmaceutical Treprostinil 20mg/20mL Injection Drugs Potential Presence of Silicone Particulate Matter Endo International, Par Pharmaceutical

FDA Novel Drug Approvals – February 2024

Mar 012024
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Letybo letibotulinumtoxinA-wlbg 2/29/2024 To temporarily improve the appearance of

FDA Drug Safety Information for February 29, 2024

Feb 292024
 

Date Brand Name(s) Description Type Reason Company  2/29/2024 Megadyne Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes Medical Devices Limit use to patients

FDA Drug Safety Information for February 27, 2024

Feb 272024
 

Date Brand Name(s) Description Type Reason Company  2/27/2024 Avanos Medical MIC* Gastric-Jejunal Feeding Tube Kits Medical Devices Potential Lack of Sterility Assurance Avanos Medical, Inc.

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