LEVAQUINŽ (levofloxacin) Tablets or Injection for PRSP and PISP in Community-Acquired Pneumonia Edward Cox, M.D. Medical Officer/DSPIDP October 20, 1999

12/1/99


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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

Author: ecox