The approval granted is for Azelaic Acid Gel, 15 per cent, which is a generic version of Finacea Gel (15 per cent) of Leo Pharma
Glenmark Pharmaceuticals has received approval from the US health regulator for Azelaic Acid gel used in treatment of acne. The approval granted to Glenmark Pharmaceuticals by by the US Food and Drug Administration (US FDA) 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.
Citing market data, the company said for the 12-month period ended September 2018, Finacea Gel (15 per cent ) achieved annual sales of approximately $ 64.1 million.
Glenmark has a portfolio comprising 143 products authorised for distribution in the US market and 56 ANDAs pending approval with the US FDA.