Zydus receives tentative approval for Topiramate tablets

MUMBAI: Cadila Healthcare today said it has received tentative USFDA approval for Topiramate Tablets, an anti-epileptic drug in multiple strengths.

In a communique to the Bombay Stock Exchange, the company said it has received the USFDA approval for Topiramate Tablets in the strengths of 25 mg, 50 mg, 100 mg and 200 mg.

It is scheduled to be launched in September 2008 upon patent expiry, it added.

The group now has 24 approvals since the commencement of filing process in financial year 2003-04. Currently the group markets 10 generics through its subsidiary Zydus Pharmaceuticals (USA) Inc.

The branded sales of Topiramate Tablets, which falls in the CNS segment, is estimated at 1.85 billion dollar in 2006 as per NDC Health.

Shares of Zydus Cadila were trading at Rs 336.50, up 0.18 per cent on Bombay Stock Exchange in afternoon trade.