Glenmark gets tentative USFDA nod for Topiramte tabs

MUMBAI: Drug major Glenmark Pharmaceuticals on Monday said it has received the United States Food and Drug Administration's (USFDA) tentative approval to market Topiramate tablets, used in the treatment of migraine.

The company has received a tentative approval from USFDA for its Abbreviated New Drug Application (ANDA), Topiramate tablets in multiple strengths of 25 mg, 50 mg, 100 mg and 200 mg, Glenmark informed the Bombay Stock Exchange.

The branded sales of Topiramate tablets, an anti-epileptic drug which falls in the central nervous system (CNS) segments, are estimated at 1.85 billion dollar in 2006 as per NDC Health.

Glenmark would manufacture the tablet at its USFDA approved manufacturing unit in Goa and its US-based subsidiary Glenmark Pharmaceuticals Inc (GPI) would market the product in that country.

With this approval, GPI now has a portfolio of 18 generic products for the US market and has over 35 ANDAs undergoing USFDA approval process.

Shares of Glenmark were trading at Rs 668.50, up 1.49 per cent on the BSE in afternoon trade.