Glenmark gets USFDA nod

New Delhi: Drug major Glenmark Pharma on Tuesday said it has received final approval from the US health regulator for Clobetasol Propionate Foam, indicated for treatment of plaque psoriasis. The approved product is a generic version of Olux-E Foam, 0.05 per cent, of Mylan Pharmaceuticals.

“Glenmark Pharmaceuticals, USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Clobetasol Propionate Foam, 0.05 per cent (emulsion formulation),” Glenmark said in a regulatory filing.

Quoting to IQVIA sales data for the 12 month period ending July 2019, Glenmark said the Olux-E Foam, 0.05 per cent, market achieved annual sales of approximately $11.1 million. Glenmark said current portfolio consists of 161 products authorised for distribution in the US marketplace and 54 abbreviated new drug applications are pending approval with the USFDA.