Glenmark gets USFDA nod for alcohol abstinence drug
New Delhi: Glenmark Pharmaceuticals on Monday said it has received US health regulator's approval to market generic version of Forest Laboratories' Campral Delayed Release Tablets, a drug used for alcohol abstinence, in the American market.
Glenmark Generics Inc, the US-based subsidiary of Glenmark Generics Ltd (GGL), has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (USFDA) for Acamprosate Calcium Delayed Release Tablets, Glenmark Pharma said in a statement.
GGL is a subsidiary of Mumbai-based Glenmark Pharmaceuticals Ltd.
Based on IMS Health sales data for the 12 month period ending March 2013, Acamprosate, which is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence, garnered sales of USD 21 million.
The Mumbai-based firm's current portfolio consists of 88 products authorised for distribution in the US market and 53 ANDA's are pending approval with the USFDA.
"In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio," the company said.
Shares of Glenmark were trading at Rs 546.85 a piece on the BSE in morning trade, down 3.77 percent from their previous close.