Monday, 21 January 2019

Glenmark receives tentative ANDA approval for Clobetasol Propionate Foam

03 December 2018 | News

It is a generic version of Olux-E®1 Foam, 0.05%, of Mylan Pharmaceuticals, Inc.

Glenmark Pharmaceuticals Inc., has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Clobetasol Propionate Foam, 0.05% (Emulsion Formulation).

It is a generic version of Olux-E®1 Foam, 0.05%, of Mylan Pharmaceuticals, Inc.

According to IQVIATM sales data for the 12 month period ending September 2018, the Olux-E® Foam, 0.05% market2 achieved annual sales of approximately $13.2 million.

Glenmark’s current portfolio consists of 144 products authorized for distribution in the U.S. marketplace and 55 ANDAs pending approval with the U.S. 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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