Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (FDA) for calcipotriene cream, 0.005 per cent, the therapeutic equivalent of Dovonex cream, 0.005 per cent of Leo Pharma A/S.
Glenmark plans to commence shipping of calcipotriene cream, 0.005 per cent immediately.
According to IMS Health sales data for the 12 month period ending April 2015, the Dovonex market achieved annual sales of approximately $91.9 million.
Glenmark’s current portfolio consists of 98 products authorized for distribution in the US marketplace and 67 ANDA’s pending approval with the US 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.