India's Lupin gets tentative FDA nod for topiramate

Fri May 30, 2008 3:07am EDT
 
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MUMBAI, May 30 (Reuters) - Indian drugmaker Lupin Ltd (LUPN.BO) said on Friday it had got tentative approval from the U.S. Food and Drug Administration to make and market multiple strengths of topiramate tablets.

The tablet, used for the treatment of seizures, is a generic version of epilepsy drug Topamax, owned by Ortho-McNeil Pharmaceutical Inc, a unit of Johnson & Johnson (JNJ.N).

Lupin has got approval to market dosages of 25 mg, 50 mg, 100 mg and 200 mg, the company said in a statement.

Topamax had sales of about $2.2 billion in the year ended March 2008, Lupin said citing U.S. market research firm IMS Health. (Reporting by Narayanan Somasundaram; Editing by Ranjit Gangadharan)

 
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