Glenmark receives US FDA nod for clotrimazole & betamethasone dipropionate cream
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (FDA) for clotrimazole and betamethasone dipropionate cream USP, 1 per cent/0.05 per cent, the therapeutic equivalent of Lotrisone cream USP, 1 per cent/0.05 per cent of Merck, Sharp and Dohme Corporation.
According to IMS Health sales data for the 12 month period ending September 2015, the Lotrisone cream USP, 1 per cent/0.05 per cent achieved annual sales of approximately $82.4 million.
Glenmark’s current portfolio consists of 103 products authorised for distribution in the US marketplace and 63 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.