Lupin Pharmaceuticals has received tentative approval for the company's abbreviated new drug application for Topiramate tablets, 25mg, 50mg, 100mg and 200mg from the FDA.
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Lupin’s Topiramate tablets are the AB-rated generic equivalent of Ortho-McNeil’s Topamax tablets, indicated for the treatment of seizures.
The product will be introduced in the market through LPI’s strong network of national wholesalers and drug stores post patent expiry in September 2008. This is expected to strengthen Lupin’s presence in the central nervous system segment.
Vinita Gupta, president and managing director of Lupin, said: “Lupin is pleased to receive this approval that will enable the company to offer Topiramate tablets as an affordable generic alternative that will have a measurable impact on the US healthcare system.”
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