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Ketek safety committee review

Executive Summary

FDA's Anti-Infective Drugs and Drug Safety & Risk Management Committees will review the benefit/risk profile of Sanofi-Aventis' antibiotic Ketek (telithromycin) during a Dec. 14-15 meeting. Labeling for Ketek was updated in June to include strengthened liver toxicity warnings (1"The Pink Sheet" July 3, 2006, p. 7). The meeting will be held at the Crowne Plaza in Silver Spring, Md., beginning at 8 a.m. both days. [Editor's note: To 2watch a webcastor order a video/DVD of this meeting, visit]...

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