Pharma major Glenmark's US generics arm has received final approval from the US Food and Drug Administration to sell riluzole tablets, indicated for the treatment of sclerosis, in 50 mg strength.
Glenmark Generics is to start shipping the tablets immediately.
Based on IMS Health sales data for the 12 month period ended March 2013, riluzole, used in treating nervous system disorder, generated sales of $64 million.
Glenmark’s current portfolio consists of 86 products authorised for distribution in the US marketplace and 52 abbreviated new drug application’s pending approval with the US FDA.