Glenmark gets USFDA nod for generic Derma-Smoothe Topical Oil

Glenmark Pharmaceuticals Tuesday said it has received final approval from the US health regulator for generic version of Derma-Smoothe Topical Oil, used in the treatment of scalp psoriasis.

"Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fluocinolone Acetonide Topical Oil, 0.01 per cent (scalp oil), a generic version of Derma-Smoothe/FS Topical Oil, 0.01 per cent (scalp oil), of Hill Dermaceuticals, Inc," the company said in a BSE filing.

For the 12 months to September 2018, DermaSmoothe/FS Topical Oil, 0.01 per cent (scalp oil), achieved annual sales of around USD 14 million, Glenmark said, citing IQVIA sales data.

The company's current portfolio consists of 141 products authorised for distribution at the US marketplace and 58 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA.