Mumbai: Drug major Glenmark Pharmaceuticals said on 2 July it has got the US Food and Drug Administration’s (USFDA) tentative approval to market Topiramate tablets, used in the treatment of migraine.
The company has received the approval 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 (BSE).
Branded sales of Topiramate tablets, an anti-epileptic drug which falls in the central nervous system (CNS) segments, are pegged at $1.85 billion 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.
Glenmark shares were trading at Rs668.50, up 1.49% on the BSE in afternoon trade.