Lupin Announces Approval Of Meloxicam Tablets

Main Category: Arthritis / Rheumatology
Article Date: 21 Jul 2006 - 0:00 PDT

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Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Meloxicam Tablets, 7.5 mg and 15 mg. The Company intends to initiate shipments immediately.

Lupin's Meloxicam Tablets are the AB-rated generic equivalent of Boehringer Ingelheim's MOBIC(R) Tablets. Meloxicam is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). It is indicated for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis. U.S. sales for MOBIC(R) Tablets were approximately $1.1 billion for the 12-month period ending December 2005 according to IMS Health.

Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc., stated, "We are extremely pleased to launch Meloxicam Tablets. The approval of our Meloxicam ANDA further reinforces Lupin's ability on submitting high-quality dossiers and gaining approval in time."

This is Lupin's 14th ANDA approval by the US FDA to date and the fourth in its fiscal year.

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 2006, the Company's Revenues and Profit after Tax were Rs.16,610 million (US$ 375 million) and Rs.1,827 million (US$ 41 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.

Lupin Pharmaceuticals, Inc.
http://www.lupinpharmaceuticals.com

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