Glenmark Pharma gets US FDA approval for generic Frova tablets 2.5 mg
Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval from the United States Food & Drug Administration (FDA) for frovatriptan succinate tablets, 2.5 mg, the therapeutic equivalent to the reference listed drug product, Frova tablets, 2.5 mg, of Endo Pharmaceuticals, Inc.
According to IMS Health sales data for the 12 month period ending January 2016, the Frova Market achieved annual sales of approximately $87.8 million.
Glenmark’s current portfolio consists of 108 products authorized for distribution in the US marketplace and 61 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.