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Glenmark pharma gets USFDA nod for generic Derma-Smoothe Topical Oil

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

Press Trust of India  |  New Delhi 

Glenmark Pharmaceuticals
Glenmark Pharmaceuticals

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

"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 $14 million, 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

The company's stock was trading at Rs 607.35 apiece, up 0.41 per cent, on the BSE at the time of filing this story.

First Published: Tue, October 30 2018. 10:45 IST
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