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FDA seeks outside review of Ketek antibiotic on December 14 and 15

The antibiotic Ketek, is under scrutiny amid reports of liver failure in a dozen patients. Ketek, approved in 2004, is also the subject of a Senate Finance Committee investigation because of the FDA's handling of the approval and of possibly faulty data.

The FDA said it would convene a public meeting of a panel of outside experts on drug safety to discuss Ketek on December 14 and 15. The committee will discuss the overall benefit to risk considerations for Ketek. The antibiotic is approved to treat acute bacterial infections of chronic bronchitis, acute bacterial sinusitis, and community-acquired pneumonia. (Reuters Ketek News)