Glenmark gets tentative nod from US FDA for azelaic acid gel

The gel is used for treating skin inflammation

Glenmark Pharmaceuticals has received tentative approval from US Food and Drug Administration (US FDA) for its generic version of azelaic acid topical gel used for treating skin inflammation. Glenmark will market this product upon receiving final approval, it said, adding that the patent for Finacea topical gel, 15 per cent, is scheduled to expire on November 18, 2018.

The tentative nod granted to Glenmark Pharmaceuticals, USA, by the US FDA is for azelaic acid gel, 15 per cent, the generic version of Finacea topical gel, 15 per cent of Bayer Healthcare, the company said in a BSE filing.

Citing IMS Health sales data, the company said for the 12 months ending December 2015, the Finacea market achieved annual sales of approximately $128 million.

The company’s current portfolio consists of 106 products authorised for distribution in the US and 62 Abbreviated New Drug Applications (ANDAs) pending approval with US FDA, it said.