Glenmark gets USFDA nod for generic version of Epiduo gel to treat acute acne

The approval granted to Glenmark Pharmaceuticals Inc by the US Food and Drug Administration is for Adapalene and Benzoyl Peroxide Gel, 0.1 per cent/2.5 per cent, which is the generic version of Epiduo gel, 0.1 per cent/2.5 per cent of Galderma Laboratories LP, the company said in a statement.

New Delhi: Glenmark Pharmaceuticals on Monday said it has received final approval from the US health regulator for generic Adapalene and Benzoyl Peroxide gel used in treatment of acute acne.

The approval granted to Glenmark Pharmaceuticals Inc by the US Food and Drug Administration is for Adapalene and Benzoyl Peroxide Gel, 0.1 per cent/2.5 per cent, which is the generic version of Epiduo gel, 0.1 per cent/2.5 per cent of Galderma Laboratories LP, the company said in a statement.

Citing IQVIA sales data for the 12 month period ending September 2019, Glenmark said Epiduo Gel, 0.1 per cent/2.5 per cent had achieved annual sales of approximately USD 33.7 million.

Read Also: Glenmark recalls over 2 lakh cartons of product in the US

The company's current portfolio consists of 163 products authorised for distribution in the US and 45 abbreviated new drug applications (ANDAs) pending approval with the USFDA.

Read Also: New USFDA warning letters show Glenmark, Lupin, Cadila Healthcare in trouble