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Glenmark Pharmaceuticals receives ANDA approval for Calcipotriene Cream

11 Jun 2015 Evaluate

Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Calcipotriene Cream, 0.005%, the therapeutic equivalent of Dovonex Cream, 0.005% of Leo Pharma. Glenmark plans to commence shipping of Calcipotriene Cream, 0.005% immediately.

The Dovonex market achieved annual sales of approximately $91.9 million, according to IMS Health sales data for the 12 month period ending April 2015.

Glenmark’s current portfolio consists of 98 products authorized for distribution in the US marketplace and 67 ANDA’s pending approval with the USFDA. 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.


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