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TEVA GRANTED TENTATIVE APPROVAL FOR GENERIC TEQUIN
Teva Pharmaceutical has received tentative approval from the FDA for its abbreviated new drug application for gatifloxacin in 200- and 400-mg tablets. Gatifloxacin is the generic equivalent of Bristol-Myers Squibb's quinolone antibiotic Tequin, which has annual sales of approximately $129 million. Teva is currently in patent litigation concerning gatifloxacin in the U.S. District Court for the Southern District of New York, where a trial is scheduled for May 1, 2006. Final approval is expected when there is a favorable decision in the case or when the mandatory stay of approval expires in June 2007, whichever occurs first.
KEYWORDS Drug Pipeline Alert
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