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FDA Grants Final ANDA Nod For Glenmark's Fluocinonide Cream

Glenmark Pharmaceuticals Ltd. said its US subsidiary Glenmark Generics Inc. had been granted final approval from US FDA for its abbreviated new drug application (ANDA) for Fluocinonide Cream USP 0.1 percent, 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 for the twelve months ended March 2014, as per IMS Health sales data.

Glenmark's current portfolio consists of 93 products authorized 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.

At the BSE, Glenmark Pharmaceuticals shares are currently trading at Rs.551.50, up 2.29 percent from the previous close.

by RTTNews Staff Writer

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