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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.

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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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