Glenmark's unit in the US, received FDA approval to market in that country generic version of Forest Laboratories’ Campral Delayed Release Tablets, used for alcohol abstinence
Glenmark Pharmaceuticals on Monday said its unit received US Food and Drug Administration (FDA) nod to market generic version of Forest Laboratories’ Campral Delayed Release Tablets, a drug used for alcohol abstinence, in the American market.
The pharmaceutical company said its unit Glenmark Generics Inc has been granted final abbreviated new drug approval (ANDA) from the FDA for Acamprosate Calcium Delayed Release Tablets.
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 $21 million.
The Mumbai-based firm’s current portfolio consists of 88 products authorised for distribution in the US market and 53 ANDAs are pending approval with the FDA.
At 3.10pm Monday, Glenmark Pharmaceuticals was trading 2.8% down at Rs552.5 on the BSE, while the 30-share Sensex was marginally up at 18,961.
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