New Delhi : Ajanta Pharma has received final approval for its generic version of acute migraine pain relief drug Zolmitriptan tablets from the US health regulator.
“The company received the final approval for Zolmitriptan tablets (2.5 mg, 5 mg) from the US Food and Drug Administration (USFDA). Zolmitriptan is used in the acute treatment of migraine and is bio-equivalent generic version of Zomig,” Ajanta Pharma said in a regulatory filing.
Zolmitriptan tablets are part of an “ever-growing portfolio” that the company has developed for the US market, the company added.
The USFDA has so far granted final approvals for nine abbreviated new drug applications (ANDAs) and two tentative approvals, it said, adding that an additional 15 ANDAs are under review.