BALTIMORE, May 30 Lupin Pharmaceuticals, Inc. (LPI)announced today that it has received tentative approval for the Company'sAbbreviated 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 ofOrtho-McNeil's TOPAMAX(R) tablets, indicated for the treatment of seizures.The brand product had annual sales of approximately $2.2 billion for thetwelve months ended March 2008, based on IMS Health sales data.
Commenting on the approval, Vinita Gupta, President and Managing Directorof Lupin Pharmaceuticals, Inc. said, "Lupin is pleased to receive thisapproval that will enable the Company to offer Topiramate tablets as anaffordable generic alternative that will have a measurable impact on the U.S.healthcare system."
The product will be introduced in the market through LPI's strong networkof national wholesalers and drug stores post patent expiry in September 2008.This will strengthen Lupin's presence in the CNS segment.
Headquartered in Mumbai, India, Lupin Limited is an innovation ledtransnational pharmaceutical company producing a wide range of quality,affordable generic and branded formulations and APIs for the developed anddeveloping markets of the world. The Company has secured global leadershipposition in Anti-TB and Cephalosporins and has a significant presence in theareas of Cardiovasculars (prils and statins), Diabetology, Asthma and NSAIDs.
The Company's R&D endeavors have resulted in significant progress in itsNCE program. The Company's foray into New Drug Delivery Systems has resultedin the development of platform technologies that are being used to developvalue-added generic pharmaceuticals.
For the financial year ended March 2008, the Lupin's Revenues and Profitafter Tax were Rs.27,730 million (US$ 694 million) and Rs.4,083 million (US$102 million) respectively. Please visit http://www.lupinworld.com for moreinformation about Lupin Ltd.
Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of LupinLimited, which is among the top six Pharmaceutical companies in India. Throughits sales and marketing headquarters in Baltimore, Maryland, LupinPharmaceuticals, Inc. is dedicated to delivering high-quality, affordablegeneric medicines trusted by healthcare professionals and patients acrossgeographies. For more information, visit http://www.lupinpharmaceuticals.com.
Safe Harbor Statement under the U. S. Private Securities Litigation ReformAct of 1995:
This release contains forward-looking statements that involve known andunknown risks, uncertainties and other factors that may cause actual resultsto be materially different from any future results, performance orachievements expressed or implied by such statements. Many of these risks,uncertainties and other factors include failure of clinical trials, delays indevelopment, registration and product approvals, changes in the competitiveenvironment, increased government control over pricing, fluctuations in thecapital and foreign exchange markets and the ability to maintain patent andother intellectual property protection. The information presented in thisrelease represents management's expectations and intentions as of this date.Lupin expressly disavows any obligation to update the information presented inthis release.TOPAMAX(R) is a registered trademark of Ortho-McNeil Neurologics, Inc. Contact: Edith St-Hilaire Senior Marketing Manager 410-576-2000 Ext. 207
SOURCE Lupin Pharmaceuticals, Inc.