FDA’s Anti-Infective Drugs Advisory Committee
Will discuss NDA (50-679) for Bristol-Myers Squibb's cephalosporin antibiotic cefepime "and the issue of bacteremic sepsis as an indication for this product" during second day of Sept. 23-24 meeting, FDA states in Aug. 25 Federal Register notice. Also on Sept. 24, the committee "will discuss the issue of pharmacokinetic parameters and microbiologic inhibitory and cidal activity data as surrogates for clinical effectiveness in the approval of new anti-infective drug products," notice states. Meeting is set for 8:30 a.m. both days at Holiday Inn, Silver Springs, Md.
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