Glenmark receives tentative approval from US FDA for locosamide oral solution

The Mumbai-headquartered Glenmark Pharmaceuticals has been granted tentative approval by the US Food and Drug Administration (FDA) for locosamide oral solution (10 mg/ml), the generic version of UCB Inc’s Vimpat oral solution. The patent listed in the Orange Book for Vimpat oral solution, which is prescribed for the treatment of epilepsy, is scheduled to expire on March 17, 2022.
 
Glenmark said that it plans to market this product upon receiving the final approval of lacosamide oral solution.
 
According to IMS Health sales data for the 12 months to January 2016, Vimpat has annual sales of around $ 55.4 million.