New Delhi: Glenmark Pharmaceuticals Friday said it has received nod from the US health regulator to market adapalene gel, used in treating acne, in the American market.
The approval was granted to its US subsidiary, Glenmark Generics Inc, for the Abbreviated New Drug Application for adapalene gel in strength of 0.1% by the US Food and Drugs Administration, the company said in a statement.
Distribution and marketing of the product in the US market will start soon, it added.
Adapalene gel is the generic equivalent of Galderma’s Differin gel, which according to IMS Health, generated sales worth around $84 million in 2009-10.
“Today’s approval expands the volume of the company’s portfolio to include a total of 15 semi solid products authorised for distribution,” the company said.
The company’s current portfolio consists of 55 products authorised for distribution in the US market and has over 50 ANDA’s approvals pending with the USFDA.
Shares of Glenmark were trading at Rs274.50 a piece on the Bombay Stock Exchange in late afternoon trade, up 1.74% from its previous close.