Glenmark receives final ANDA approval for Desoximetasone Ointment USP, 0.25%

23 Sep 2013 Evaluate

Glenmark Generics Inc., USA the subsidiary of Glenmark Generics has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Desoximetasone Ointment USP, 0.25% their generic version of Topicort by Taro Pharmaceuticals USA Inc and shipping will commence immediately.

Desoximetasone Ointment 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 June 2013, Desoximetasone Ointment garnered annual sales of approximately $ 40 million.

Glenmark's current portfolio consists of 89 products authorized for distribution in the U.S. marketplace and 54 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.

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