BALTIMORE, July 17 /PRNewswire/ — Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base). Commercial shipments of Amlodipine Besylate Tablets will commence shortly.
Lupin’s Amlodipine Besylate Tablets are the AB-rated generic equivalent of Pfizer’s Norvasc(R) Tablets, a long-acting calcium channel blocker indicated for the treatment of hypertension. The brand product had annual sales of approximately $2.7 billion for the twelve months ended December 2006, based on IMS Health sales data.
Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, “We are pleased with the approval of Amlodipine Besylate tablets.” Ms. Gupta added, “This approval broadens our growing portfolio of cardiovascular medications, and we look forward to offering this cost-effective alternative to patients in the U.S.”
About Lupin
Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with a strong research focus. It has a program for developing New Chemical Entities. The Company has a state-of-the-art R&D center in Pune. The Company is a leading global player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular drugs (prils and statins) and has a notable presence in the areas of diabetology, NSAIDs and Asthma.
For the financial year ended March 2007, the Lupin’s Revenues and Profit after Tax were Rs.20,289 million (US$ 475 million) and Rs.3,021 million (US$ 70 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 five 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
*Norvasc(R) is a registered trademark of Pfizer, Inc. For More Information: Contact: Edith St-Hilaire Senior Marketing Manager 410-576-2000
Lupin Pharmaceuticals, Inc.
CONTACT: Edith St-Hilaire, Senior Marketing Manager, +1-410-576-2000,for Lupin Pharmaceuticals, Inc.
Web site: http://www.lupinpharmaceuticals.com/
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