Zydus Life gets final USFDA nod for hypotension injection

Zydus Lifesciences, on May 17 received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market the Ephedrine Sulfate Injection USP, 50 mg/mL single-dose vials. The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara.

The Ephedrine Sulfate injection is used for the treatment of clinically important hypotension that occurs in the setting of anesthesia. The injection witnessed an annual sales of $52 million in the United States. The company now has a total 368 approvals and has filed over 440 abbreviated new drug applications, so far.

Zydus Life is expected to report its fourth quarter earnings on Thursday, May 18. In the third quarter of FY23 the company reported a profit growth of nearly 12 percent from the same period in the previous year, while the EBITDA margin rose 130 basis points to 21.9 percent from 20.6 percent in same quarter in FY22. The pharma company reported a 17 percent rise in its US sales as well to $234 million.