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Corporate - Regulatory Bodies & Rulings
Tentative nod for Zydus drug

Our Bureau

Ahmedabad June 6 The Ahmedabad-based Cadila Healthcare Ltd (Zydus Cadila) has received tentative approval for Topiramate tablets in the strengths of 25 mg, 50 mg, 100 mg and 200 mg from the US Food and Drug Administration (USFDA).

The branded sales of Topiramate tablets, an anti-epileptic drug, which falls in the CNS segment, is estimated at $1.85 billion in 2006 as per NDC Health. It is scheduled to be launched in September 2008 upon patent expiry, a Zydus release said here on Wednesday.

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 in the USA.

More Stories on : Regulatory Bodies & Rulings | Pharmaceuticals

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