Skip to main content

Zydus receives final approval from the USFDA for Ephedrine Sulfate Injection

 

Clinical courses

Zydus receives final approval from the USFDA for Ephedrine Sulfate Injection

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Ephedrine Sulfate Injection USP, 50 mg/mL single-dose vials (USRLD: Akovaz® Injection).

Ephedrine Sulfate Injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara (India).

Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States (IQVIA MAT Mar. 2023).