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FDA Anti-Infective Drugs Advisory Committee

Executive Summary

Will meet July 22 to discuss efficacy supplement NDA (50- 605/S-017) for Glaxo's Ceftin (cefuroxime axetil) for treatment of early Lyme disease. On the morning of July 23, the committee will discuss a proposed addition to the Division of Anti-Infective Drug Products' antimicrobial points to consider clinical trials document. "This addition concerns guidance on the conduct and analysis of clinical trials of antimicrobial drug products in the treatment of sepsis and potential product labeling for products establishing effectiveness in the treatment of sepsis," a June 25 Federal Register notice states. In the afternoon of July 23, the committee will turn to a discussion of the use of quinolone-class antimicrobials as investigational drugs in children. Meetings will begin both days at 8:30 a.m. in conference rooms D and E.
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