Healthcare Industry News:  Lupin Pharmaceuticals 

Biopharmaceuticals Generics FDA

 News Release - May 8, 2007

Lupin Announces Final FDA Approval of Cefdinir for Oral Suspension, 250 mg/5 mL, Launches Entire Product Family

BALTIMORE, May 8 (HSMN NewsFeed) -- Lupin Pharmaceuticals, Inc. announced today that it was granted final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Cefdinir for Oral Suspension, 250 mg/5mL. Lupin was the first company to receive final approval from the FDA for the capsule form and the lower strength suspension on May 19, 2006 and May 31, 2006, respectively. Commercial shipment in the U.S. has already commenced.

Lupin's Cefdinir capsules and suspensions are the AB-rated generic equivalent of Abbott Laboratories' Omnicef® which had U.S. sales of approximately $787 million for the 12-month period ending December 31, 2006, according to IMS Health. Cefdinir is indicated for the treatment of patients with mild to moderate infections caused by susceptible bacteria.

Commenting on the final approval of the 250 mg/5 mL suspension, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, "We are extremely pleased with the approval of the double strength suspension and look forward to offering the entire product line to our customers." Ms. Gupta added, "This approval of Cefdinir suspension reinforces Lupin's ability on submitting high quality dossiers and gaining approvals on time."

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 nine-month period ended December 2006, the Company's Revenues and Profit after Tax were Rs.14,985 million (US$ 335 million) and Rs.1,650 million (US$ 37 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

Omnicef® is a registered trademark of Abbott Laboratories.


Source: Lupin Pharmaceuticals

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