Cadila Healthcare Ltd has received tentative approval for topiramate tablets in the strengths of 25 mg, 50 mg, 100 mg and 200 mg from the US FDA. The branded sales of topiramate tablets, an anti-epileptic drug, which falls in the CNS segment, is estimated at USD 1.85 bn in 2006 as per NDC Health. It is scheduled to be launch, 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 (USA) Inc.