Glenmark Pharma’s eczema drug granted tentative US FDA approval

Glenmark Pharmaceuticals Monday said it has received tentative nod from the US health regulator for Clobetasol Propionate foam, used to treat inflammation and itching caused by a number of skin conditions like eczema. Glenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food & Drug Administration (US FDA) for Clobetasol Propionate Foam, 0.05 per cent (Emulsion Formulation), the company said in a BSE filing. The approved product is a generic version of Mylan Pharmaceuticals Inc’s Olux-E Foam, 0.05 per cent. Quoting IQVIA sales data for the 12-month period ended September 2018, Glenmark Pharmaceuticals said, Olux-E Foam achieved annual sales of around $13.2 million. The company’s current portfolio consists of 144 products authorised for distribution in the US market and 55 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it added.

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