Zydus Cadila gets US FDA nod for anti-epileptic tablets

Written by Agencies | Mumbai | Updated: Mar 31 2009, 20:38pm hrs
Drug maker Zydus Cadila on Tuesday said it has received final approval from the US drug regulator for its anti-epileptic drug, Topiramate.

The company has received the final approval from the US Food and Drug Administration (FDA) to market Topiramate tablets, Cadila Healthcare, the flagship company of Zydus Cadila group, said in a filing to the Bombay Stock Exchange.

The approval is for the tablets in the strengths of 25 mg, 50 mg, 100 mg and 200 mg, it further said.

After this approval, the group now has 42 approvals and has so far filed 83 Abbreviated New Drug Applications (ANDAs) with the US drug regulator.

This month itself, four other Indian drug firms -- Ranbaxy, Sun Pharma, Aurobindo and Unichem Laboratories -- have received nod from the US FDA for the same tablets in different strengths.

Shares of Cadila Healthcare were trading at Rs 274, up 1 per cent on the BSE.