BALTIMORE, May 30 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. (LPI) announced today that it 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(R) tablets, indicated for the treatment of seizures. The brand product had annual sales of approximately $2.2 billion for the twelve months ended March 2008, based on IMS Health sales data.
Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, "Lupin is pleased to receive this approval that will enable the Company to offer Topiramate tablets as an affordable generic alternative that will have a measurable impact on the U.S. healthcare system."
The product will be introduced in the market through LPI's strong network of national wholesalers and drug stores post patent expiry in September 2008. This will strengthen Lupin's presence in the CNS segment.
Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world. The Company has secured global leadership position in Anti-TB and Cephalosporins and has a significant presence in the areas of Cardiovasculars (prils and statins), Diabetology, Asthma and NSAIDs.
The Company's R&D endeavors have resulted in significant progress in its NCE program. The Company's foray into New Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.
For the financial year ended March 2008, the Lupin's Revenues and
Profit after Tax were Rs.27,730 million (US$ 694 million) and Rs.4
|SOURCE Lupin Pharmaceuticals, Inc.|
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