Lupin gets tentative approval from USFDA

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New Delhi, May 30 (UNI) Pharmaceutical major Lupin Ltd today said it has received tentative approval for its marketing application for a generic version of Topiramate tablets in four dosages from the US drug regulator, Food and Drug Administration (FDA).

Topiramate tablets are generic equivalents of Ortho-Mcneil's Topamax tablets, indicated for the treatment of seizures.

The brand product had annual sales of approximately 2.2 billion dollars for the 12 months ended March 2008, based on IMS Health sales data, a company statement said.

Lupin will launch the drug in the US post patent expiry of the drug in September 2008, it added.

With this approval, Lupin has 29 abbreviated new drug applications (ANDA) approvals in the US market, with another 34 pending for approval.


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