Lupin Receives US FDA Tentative Approval For Memantine HCl Tablets

Main Category: Alzheimer's / Dementia
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 26 Jan 2010 - 1:00 PDT

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Lupin Pharmaceuticals, Inc. (LPI) announced that it has received tentative approval from the US Food and Drug Administration (US FDA) for its Memantine Hydrochloride tablets, 5mg and 10mg.

Lupin's Memantine HCl tablets are AB-rated to Namenda® tablets indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Namenda had annual sales of approximately $1.1 billion for the twelve months ended September 2009, based on IMS Health sales data.

Commenting on the approval, Vinita Gupta, President and CEO of Lupin Pharmaceuticals, Inc., said, "We are pleased to receive this tentative approval and look forward to bringing Memantine HCl tablets to the US market as an affordable generic alternative post patent expiry."

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 today has significant market share in key markets in the Cardiovasculars (prils and statins), Diabetology, Asthma, Pediatrics, CNS, GI, Anti-Infectives and NSAIDs therapy segments, not to mention global leadership positions in the Anti-TB and Cephalosporins. The Company's R&D endeavors have resulted in significant progress in its NCE program. The Company's foray into Advanced Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.

Our Drugs and products reach over 70 countries in the world. Today, Lupin has the unique distinction of being the fastest growing top 10 Generics players in the two largest pharmaceutical markets of the world -- The U.S. (ranked 9th by prescriptions & growing at 92%) and Japan (ranked 7th and growing at 23%). The company is also the fastest growing, top 5 pharmaceutical players in India (ORG IMS - March 2009) and the fastest growing Generic player in South Africa (ranked 6th and growing at over 30 % YoY - IMS)

For the financial year ended March 2009, Lupin's Consolidated Revenues and Profit after Tax were Rs.39,145 million (US$ 851 million) and Rs. 5015 million (US$ 109 million) respectively.

Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited. 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.

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.

Namenda® is a registered trademark of Forest Laboratories, Inc.

Source: Lupin Pharmaceuticals, Inc

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