Glenmark Pharma receives ANDA approval for Calcipotriene Cream, 0.005%

India Infoline News Service | Mumbai | June 11, 2015 08:48 IST

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

According to IMS Health sales data for the 12 month period ending April 2015, the Dovonex market1 achieved annual sales of approximately $ 91.9 million.

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