Last Updated on October 11, 2024 by The Health Master
Ahmedabad: Zydus Lifesciences Limited (Zydus) has announced that it 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 anaesthesia.
The drug will be manufactured at the group’s Jarod, close to Vadodara, injectable manufacturing facility.
According to IQVIA MAT March 2023, ephedrine sulfate injection USP, 50 mg/mL, had yearly sales of $52 million in the United States.
With this, the group now has 368 approvals and has so far filed over 440 ANDAs as of December 31, 2022, since the commencement of the filing process in FY 2003–04.
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