Table of Contents
LEVAQUINŽ (levofloxacin) Tablets or Injection for PRSP and PISP in Community-Acquired Pneumonia Edward Cox, M.D. Medical Officer/DSPIDP October 20, 1999
LEVAQUINŽ for PRSP/PISP in CAP
LEVAQUINŽ for PRSP/PISP in CAP
LEVAQUINŽ for the Treatment of CAP and S. pneumoniae in CAP Original NDA
LEVAQUINŽ for CAP Original NDA Studies
LEVAQUINŽ for CAP (NDA) Patient Characteristics- Clinically Evaluable Population
LEVAQUINŽ for CAP (NDA) Study K90-071
LEVAQUINŽ for CAP (NDA) Study M92-075
LEVAQUINŽ for the Treatment of PRSP/PISP in CAP Supplemental NDA
PRSP/PISP in CAP Clinical Trials
PRSP/PISP in CAP Clinical Trials
PRSP/PISP in CAP Clinical Trials
PRSP/PISP in CAP FDA Efficacy Analysis - Approach
PRSP/PISP in CAP FDA Efficacy Analysis - Approach
PRSP/PISP in CAP FDA Efficacy Analysis - Populations
PRSP/PISP in CAP Patient Characteristics - LEVAQUINŽ
PRSP/PISP in CAP Patient Characteristics - Comparator
PRSP/PISP in CAP Source of Patients - LEVAQUIN-Treated Patients
PRSP/PISP in CAP - Efficacy Results LEVAQUINŽ
PRSP/PISP in CAP LEVAQUINŽ FDA Clinical Efficacy and Micro Efficacy
PRSP/PISP in CAP - Efficacy Results Comparator
PRSP/PISP in CAP Comparator FDA Clinical Efficacy and Micro Efficacy
Cross-Resistance PRSP & PISP Levofloxacin-Treated Patients
LEVAQUINŽ for PRSP/PISP in CAP Summary - Original NDA
LEVAQUINŽ for PRSP/PISP in CAP Summary - Supplemental NDA
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