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Lupin Pharmaceuticals, Inc. Receives US FDA Approval for Simvastatin Tablets |
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16 May 2007 |
Lupin Pharmaceuticals, Inc. announced today that it has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Simvastatin Tablets 10mg, 20mg, 40mg and 80mg.
BALTIMORE, MD, USA | May 15, 2007 | Lupin Pharmaceuticals, Inc. announced today that it has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Simvastatin Tablets 10mg, 20mg, 40mg and 80mg.
Lupin's Simvastatin Tablets are the AB-rated generic equivalent of Merck's Zocor(R) tablets. Simvastatin is indicated for the treatment of high cholesterol.
Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. commented, "We are delighted to receive final FDA approval for Simvastatin Tablets. The addition of generic Zocor(R) complements Lupin's commitment to bringing high-quality, low cost drug alternatives to the American public."
With this approval, Lupin now has 21 ANDAs approved by the US FDA.
About Lupin
Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with strong research focus. It has a program for developing New Chemical Entities. The Company has 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, Lupin's Revenues and Profit after Tax were Rs.20, 289 million (US$ 475 million) and Rs. 3,021 million (US$ 70 million) respectively.
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
*Zocor(R) is a registered trademark of MERCK & CO., Inc.
SOURCE: Lupin Pharmaceuticals, Inc. |
