Lupin Receives USFDA Approval For Topiramate Tablets
Lupin Pharmaceuticals has received tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Topiramate 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, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. 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 LPI's strong network of national wholesalers and drug stores post patent expiry in September 2008. This will strengthen Lupin's presence in the CNS segment.