New York : Glenmark Pharmaceuticals has received tentative approval from the US health regulator USFDA for the generic version of Galderma Laboratories LP’s Epiduo gel used in the treatment of acne.
“Glenmark Pharmaceuticals, USA, has been granted tentative approval by the US Food and Drug Administration (USFDA) for adapalene and benzoyl peroxide gel, 0.1 per cent/ 2.5 per cent,” it said in a BSE filing.
Adapalene and benzoyl peroxide gel is generic version of Galderma Laboratories LP’s Epiduo.
According to IMS Health sales data for the 12 months to February 2016, Glenmark said Epiduo gel achieved annual sales of around USD 351.8 million.
The company’s current portfolio consists of 112 products authorised for distribution in the US marketplace and 58 ANDA pending approvals with USFDA.