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Ofloxacin receives FDA approval.
2003 OCT 2 - (NewsRx.com & NewsRx.net) -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), has received final approval from the U.S. Food and Drug Administration (FDA) to manufacture and market ofloxacin tablets 200 mg, 300 mg, and 400 mg.
The Office of Generic Drugs, FDA, has determined Ranbaxy's ofloxacin tablets to be bioequivalent and, therefore, therapeutically equivalent to the listed drug (Floxin Tablets, 200 mg, 300 mg, and 400 mg, respectively, of Ortho McNeil Pharmaceutical, Inc.). In 2002, sales for Ofloxacin Tablets totaled US$29.8M.
Ofloxacin tablets (Floxin) are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms in the infections listed as follows:
Acute bacterial exacerbations of chronic bronchitis; community-acquired pneumonia; uncomplicated skin ...
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