New Delhi: Ajanta Pharma has received final approval for its generic version of acute migraine pain relief drug almotriptan malate tablets from the US health regulator.
The approval by the US Food and Drug Administration (USFDA) is for multiple strengths of 6.25mg and 12.5mg of the generic version of Janssen Pharmaceuticals’ Axert tablets, Ajanta Pharma said in a BSE filing.
Ajanta Pharma USA Inc, a wholly-owned subsidiary of the company, is scheduled to launch the almotriptan malate tablets in the US shortly, it said.
Almotriptan tablets is a 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 eight abbreviated new drug applications (ANDAs) and two tentative approvals, it said, adding that an additional 16 ANDAs are under review.