Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (FDA) for clobetasol propionate topical solution USP, 0.05%, the generic version of Temovate topical solution, 0.05%, of Fougera Pharmaceuticals, Inc. This product will be manufactured at Glenmark’s Baddi plant in India.
According to IQVIA sales data for the 12 month period ending February 2018, the Temovate topical solution, 0.05% market achieved annual sales of approximately $46.2 million.
Glenmark’s current portfolio consists of 133 products authorized for distribution in the US marketplace and 60 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.