Glenmark Receives FDA Tentative Approval for Mylan Generic

| By | FDA, Generics, Glenmark, Mylan

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Clindamycin Phosphate Foam, 1%, a generic version of EVOCLIN®1 Foam, 1%, of Mylan Pharmaceuticals Inc.

According to IQVIA sales data for the 12 month period ending April 2019, the Evoclin Foam, 1% market achieved annual sales of approximately $17.0 million.

Glenmark’s current portfolio consists of 156 products authorized for distribution in the US marketplace and 59 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.

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