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 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.
About Lupin
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.4,083
million (US$ 102 million) respectively. Please visit
http://www.lupinworld.com for more information about Lupin Ltd.
Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of
Lupin Limited, which is among the top six Pharmaceutical companies in
India. Through its sales and marketing headquarters in Baltimore, Maryland,
Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality,
affordable generic medicines trusted by healthcare professionals and
patients across geographies. For more information, visit
http://www.lupinpharmaceuticals.com.
Safe Harbor Statement under the U. S. Private Securities Litigation
Reform Act of 1995:
This release contains forward-looking statements that involve known and
unknown risks, uncertainties and other factors that may cause actual
results to be materially different from any future results, performance or
achievements expressed or implied by such statements. Many of these risks,
uncertainties and other factors include failure of clinical trials, delays
in development, registration and product approvals, changes in the
competitive environment, increased government control over pricing,
fluctuations in the capital and foreign exchange markets and the ability to
maintain patent and other intellectual property protection. The information
presented in this release represents management's expectations and
intentions as of this date. Lupin expressly disavows any obligation to
update the information presented in this release.
TOPAMAX(R) is a registered trademark of Ortho-McNeil Neurologics, Inc.
Contact: Edith St-Hilaire
Senior Marketing Manager
410-576-2000 Ext. 207
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Via: Healthcare
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