Glenmark gets tentative US FDA nod for Topiramte

New Delhi, July 2: Pharma company Glenmark Pharmaceuticals today said it has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Tablets.

The drug, an anti-epileptic, is available in the multiple strengths of 25 mg, 50 mg, 100 mg and 200 mg, a statement said.

The branded sale of Topiramate tablets was estimated at 1.85 billion dollars in '06.

The company will manufacture the finished dose formulation at its manufacturing facility in Goa. Glenmark Pharmaceuticals Inc, US (GPI) will begin marketing the product in the US upon patent expiry.

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

UNI