Glenmark Generics Inc., USA, the subsidiary of Glenmark Generics (GGL), 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%, 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. Fluocinonide Cream garnered annual sales of around $103 million.
Glenmark Pharmaceuticals current portfolio consists of 93 products authorized for distribution in the U.S. marketplace and 71 ANDA’s pending approval with the U.S. 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.
Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals and aims to be a global integrated Generic and API leader. GGL has an established presence in North America and developing an EU presence.
