Lupin receives USFDA Approval for Topiramate Tablets

Lupin Ltd has announced today that it has received tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Topiramatc tablets, 25 mg, 50 mg, 100 mg and 200 mg from the U.S. Food and Drug Administration (USFDA).Lupin's Topiramate tablets are the AB-rated generic equivalent of Ortho-McNeil's TOPAMAX tablets, indicated for the treatment of seizures. The brand product had annual sales of approximately $2.2 billion for the twelve months ended March 2008, based on IMS Health sales data.Commenting on the approval, Dr. Kamal Sharma, Managing Director, 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 U.S. healthcare system."The product will be introduced in the market through LPIs strong network of national wholesales and drug stores post patent expiry in Sep 2008. This will strengthen Lupin's presence in the CNS segment. With the approval of Topiramate tablets the cumulative ANDA approvals stands at 29 (including 3 tentative approvals) with 34 pending approvals from the USFDA.The stock closed the day at Rs.710.95, up by Rs.6.30 or 0.89%. The stock hit an intraday high of Rs.732.10 and low of Rs.697.The total traded quantity was 190639 compared to 2 week average of 99932.