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Zydus Gets USFDA approval For Anaesthesia Drug
- By Newsdesk
- New Delhi
- May 19, 2023
The United States Food and Drug Administration (USFDA) has given Zydus Lifesciences final approval to manufacture and market Ephedrine Sulphate Injection USP, 50 mg/mL single-dose vials. The medication is the generic analogous of the FDA-approved drug Akovaz Injection.
Ephedrine Sulphate Injection is used for the treatment of clinically significant hypotension that occurs during anaesthesia. The drug will be produced at the group's injectable manufacturing plant in Jarod, India, near Vadodara.
In the United States, Ephedrine Sulphate Injection USP, 50 mg/mL had annual sales of USD 52 million (IQVIA MAT Mar. 2023). Since the beginning of the filing process in FY 2003-04, the group has received 368 approvals and has filed over 440* ANDAs.