Glenmark receives USFDA approval for Clotrimazole, Betamethasone Dipropionate Cream

09 Nov 2015 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Clotrimazole and Betamethasone Dipropionate Cream USP, 1% 0.05%, the therapeutic equivalent of Lotrisone Cream USP, 1% 0.05% 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% 0.05% market1 achieved annual sales of approximately $82.4 million.

Glenmark’s current portfolio consists of 103 products authorized for distribution in the US marketplace and 63 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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