FDA Eyes Sanofi Antibiotic Over Safety Concerns

Law360, New York (November 15, 2006, 12:00 AM EST) -- The U.S. Food and Drug Administration has asked a joint panel of outside experts to turn the spotlight on a bronchitis treatment marketed by pharmaceutical giant Sanofi-Aventis SA amid concerns over the antibiotic’s possible link to severe liver problems and several deaths.

The agency said in a federal notice on Tuesday that it wants the panel to discuss the overall risks and benefits of Ketek – also known as also telithromycin – during a meeting on Dec. 14 and 15. The two-day review could result in...
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