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  5. FDA Rationale for Recognition Decision: Levofloxacin
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FDA Rationale for Recognition Decision: Levofloxacin

FDA has reviewed the published literature and the CLSI Rationale Document that includes non-clinical pharmacokinetic and pharmacodynamic analyses and probability of target attainment analyses. FDA agrees with these analyses and agrees that these analyses support a reduction in the breakpoints for both Enterobacteriaceae and P. aeruginosa as listed in the recognized standard. FDA agrees that the recognized STIC are based on the dosing regimen described in the recognized standard.