USFDA nod to Glenmark acne gel

Glenmark Pharmaceuticals Friday said it has received final approval from the US health regulator for its generic version of BenzaClin gel used in the treatment of acne. The approval granted to Glenmark Pharmaceuticals Inc, USA (Glenmark) by the United States Food & Drug Administration (USFDA) is for Clindamycin and Benzoyl Peroxide Gel, 1 per cent|5 per cent, a generic version of BenzaClin1 Gel, 1 per cent|5 per cent, of Valeant Bermuda, the company said in a statement.

Citing IQVIATM sales data, Glenmark said BenzaClin Gel, 1 per cent |5 per cent had sales of USD 99.4 million in the 12-month period ended January 2019. Glenmark's current portfolio consists of 151 products authorised for distribution in the US with 53 ANDA's (abbreviated new drug applications) pending approval with the USFDA.