Telithromycin (KETEK™) Drug-Resistant S. pneumoniae

5/16/01


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Table of Contents

Telithromycin (KETEK™) Drug-Resistant S. pneumoniae

Overview

Proposed Label for Drug Resistance • Community-acquired pneumonia and • Acute sinusitis “due to S. pneumoniae, including strains resistant to penicillin G and erythromycin A ...”

Penicillin-resistant S. pneumoniae (PRSP)

Regulatory History of PRSP Labeling

Regulatory History: Community-acquired Pneumonia due to PRSP

Levofloxacin

Levofloxacin Label

Moxifloxacin

Linezolid

CAP- PRSP Labeling (cont’d.)

Telithromycin - PRSP CAP *

PRSP (CAP) - Summary

Telithromycin & Erythromycin-resistant S. pneumoniae (ERSP)

Telithromycin - ERSP CAP*

MICs of ERSP Cases* : mefE genotype

ERSP (CAP) - Summary

Author: CDER.USER