Glenmark Pharma gets US FDA approval for generic Elidel cream

Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (FDA) for pimecrolimus cream, 1%, a generic version of Elidel cream, 1%, of Bausch Health US, LLC. According to IQVIA sales data for the 12 month period ending July 2019, the Elidel cream,1% market achieved annual sales of approximately $198.8 million. Glenmark’s current portfolio consists of 160 products authorized for distribution in the US marketplace and 55 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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