Sunday, 16 December 2018

Glenmark gets USFDA nod for generic acne treatment gel

20 November 2018 | News

The approval granted to Glenmark Pharmaceuticals Inc by by the US Food and Drug Administration (USFDA) is for Azelaic Acid Gel, 15 per cent, which is a generic version of Finacea Gel (15 per cent) of Leo Pharma

Representative Image

Representative Image

Glenmark Pharmaceuticals has said that it has received approval from the US health regulator for Azelaic Acid gel used in treatment of acne.

The approval granted to Glenmark Pharmaceuticals Inc by the US Food and Drug Administration (USFDA) is for Azelaic Acid Gel, 15 per cent, which is a generic version of Finacea Gel (15 per cent) of Leo Pharma, the company said in a statement.

Glenmark Pharmaceuticals has said that it has received approval from the US health regulator for Azelaic Acid gel used in treatment of acne.

The approval granted to Glenmark Pharmaceuticals Inc by by the US Food and Drug Administration (USFDA) is for Azelaic Acid Gel, 15 per cent, which is a generic version of Finacea Gel (15 per cent) of Leo Pharma, the company said in a statement.

According to the news reported by PTI, citing market data, the company said for the 12-month period ended September 2018, Finacea Gel (15 per cent ) achieved annual sales of approximately USD 64.1 million.

Glenmark has a portfolio comprising 143 products authorised for distribution in the US market and 56 ANDAs pending approval with the USFDA.

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