Glenmark receives FDA nod to market epilepsy drug

MUMBAI: Glenmark Pharmaceuticals has received the final approval from the US Food and Drug Administration for marketing Oxcarbazepine tablets, the first generic version of Trileptal.

Trileptal is a widely used FDA approved medication to treat epilepsy, which directly affects the nervous system. The company has been awarded exclusivity to market the drug in 150 mg, 300 mg and 600 mg for 180 days. According to IMS Health, Oxcarbazepine sales were $643 million, for the 12-month period (July-June).

With this approval, Glenmark Pharmaceuticals has a portfolio of 20 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process. At 12:30 pm, Glenmark Pharmaceuticals shares were up 1.6 per cent at Rs 415 on BSE.