Zydus Lifesciences gets USFDA’s final nod for Ephedrine Sulfate Injection

17 May 2023 Evaluate

Zydus Lifesciences 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 $52 million in the United States (IQVIA MAT Mar. 2023). The group now has 368 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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