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Tentative Approval Granted for Levofloxacin Tablets

PRINCETON, N.J., Sept. 10 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Levofloxacin Tablets, 250 mg, 500 mg, and 750 mg. Total market sales for Levofloxacin tablets were $1.27 billion with a growth rate of 18% (IMS - MAT: June 2004).

Levofloxacin is indicated for the treatment of adults (>/=18 years of age) with mild, moderate, and severe infections caused by susceptible strains of designated microorganisms in the conditions listed as follows: Acute maxillary sinusitis; Acute bacterial exacerbation of chronic bronchitis; Nosocomial pneumonia; Community-acquired pneumonia; Complicated skin and skin structure infections; Uncomplicated skin and skin structure infections (mild to moderate); Chronic bacterial Prostatitis; Complicated urinary tract infections(mild to moderate); Acute pyelonephritis (mild to moderate) and Uncomplicated urinary tract infections (mild to moderate).

"We are delighted to receive this tentative approval for a product that has both utility and value in the management of patients suffering from bacterial infections. We are proud to offer this product as an affordable generic alternative, under the Ranbaxy Pharmaceuticals Inc. label. We will launch Levofloxacin tablets at the time that final product approval is received from the U.S. FDA," according to Jim Meehan, Vice President of Sales and Marketing for RPI.

Source: Ranbaxy Pharmaceuticals Inc.

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