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
|