Glenmark gets tentative nod from USFDA for azelaic acid gel

The patent for Finacea topical gel, 15%, is scheduled to expire on November 18, 2018

Glenmark's Nalagarh plant in HP
Press Trust of India New Delhi
Last Updated : Feb 17 2016 | 1:04 PM IST
Glenmark Pharmaceuticals today announced receipt of tentative approval from USFDA 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%, is scheduled to expire on November 18, 2018.

The tentative nod granted to Glenmark Pharmaceuticals Inc, USA, by the US Food and Drug Administration (USFDA) is for azelaic acid gel, 15%, the generic version of Finacea topical gel, 15% 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.

ALSO READ: Glenmark Pharma gets USFDA nod for two generic drugs


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 USFDA, it said.

The stock was trading at Rs 708 in the mid-day trade, up 0.54% from the previous close.
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First Published: Feb 17 2016 | 12:42 PM IST

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