Glenmark Generics (GGI), a US subsidiary of the Glenmark Generics, has been granted final abbreviated new drug approval (ANDA) from the US FDA for acamprosate calcium delayed release tablets, its generic version of Forest Laboratories’ Campral delayed release tablets.
Acamprosate is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence.
Based on IMS Health sales data for the 12-month period ending March 2013, acamprosate garnered sales of $21 million. Glenmark’s current portfolio consists of 88 products authorised for distribution in the US marketplace and 53 ANDA’s pending approval with the US FDA. 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.
EP News Bureau – Mumbai