Glenmark gets USFDA nod for generic Derma-Smoothe Topical Oil

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

The company said,"Glenmark Pharmaceuticals, USA (Glenmark) has been granted final approval by the US 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."

For the 12 months 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. The company’s stock was trading at ₹ 607.35 apiece, up 0.41 per cent, on the BSE.

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