FDA tentatively approves Lupin's generic Topamax


WASHINGTON The Food and Drug Administration issued a tentative approval for Indian drug manufacturer Lupin’s application for a generic seizure medication on Friday, the company announced.

The company’s application covers 50mg, 100mg and 200mg tablets of the drug Topiramate, a generic equivalent to Johnson & Johnson’s Topamax, indicated for the treatment of epileptic seizures and migraines.

Based in Mumbai, India, Lupin specializes drugs for the treatment of drugs to treat tuberculosis, bacterial infections and cardiovascular disease. It has offices in the U.S., U.K., Russia, Uzbekistan, Kazakhstan and Thailand.

Sales of Topamax reached $1.8 billion in the first nine months of 2007, according to SEC filings. According to the Wall Street Journal, J&J’s patent for Topamax will expire Sept. 26. In March, a court in New Jersey upheld an injunction issued in 2006 preventing Canonsburg, Pa.-based Mylan Laboratories from marketing a generic equivalent to Topamax until the patent expires.

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