Glenmark Pharma gets final USFDA nod for migraine drug

NEW DELHI: Glenmark Pharma has received final nod from the USFDA to manufacture and market therapeutical equivalent of Endo Pharmaceutical’s Frova tablets, used to treat migraine headaches, in the US market.

"Glenmark Pharmaceuticals Inc has been granted final approval by the US Food and Drug Administration (USFDA) for Frovatriptan Succinate Tablets, 2.5 mg," the company said in a BSE filing on Monday.

It also said the drug is "therapeutical equivalent of Endo Pharmaceutical’s Frova tablets 2.5 mg." Quoting IMS data, Glenmark said the approved product has an estimated market size of $87.8 million for the 12 months ended January 2016. The company’s current portfolio consists of 61 ANDAs pending approvals from the USFDA and 108 products authorised for distribution in the US.