Zydus receives USFDA tentative approval for Topiramate tablets

Mumbai, June 6 (UNI) Cadila Healthcare's subsidiary Zydus Pharmaceuticals has received the tentative approval from the US Food and Drugs Administration (USFDA) for its Topiramate tablets, an anti-epileptic drug.

Cadila Healthcare today announced that the company has received tentative approval for tablets in the strengths of 25 mg, 50 mg, 100 mg and 200 mg from the USFDA.

The company said that the branded sales of Topiramate tablets, which falls in the CNS segment, is estimated at USD 1.85 billion last year as per NDC Health.

It is scheduled to be launched in September 2008 upon patent expiry. The group now has 24 approvals since the commencement of filing process in FY 2003-04. Currently the group markets 10 generics through its subsidiary Zydus Pharmaceuticals.

UNI