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Friday, October 26, 2007

FDA: Sanofi-Aventis failed to stop abuses in study of antibiotic

C-Health: "U.S. government investigators say drug maker Sanofi-Aventis ignored misconduct by doctors who helped test an antibiotic that was later linked to several deaths. The Food and Drug Administration sent a letter to Sanofi on Oct. 23, detailing problems with a 1,800-patient study of Ketek in 2002. The U.S. Congress has been investigating FDA's approval of the drug since last year after several users developed serious liver problems and died. "

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