Glenmark Generics Inc., USA, the subsidiary of Glenmark Generics Limited, has been granted final approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for fluocinonide cream USP 0.1 per cent, the generic version of Vanos Cream by Medicis.
Fluocinonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. According to IMS Health sales data for the 12 month period ending March 2014, fluocinonide cream garnered annual sales of approximately USD 103 million.
Glenmark’s current portfolio consists of 93 products authorised for distribution in the US marketplace and 71 ANDA’s pending approval with the US FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.