Table of Contents
Ketek? (telithromycin) NDA Background
Telithromycin - Background
Telithromycin - Regulatory History
Telithromycin - April 2001 Advisory Committee
Telithromycin- April 2001 Advisory
CAP: Clinical Response -TOC
AECB: Clinical Response -TOC
Sinusitis: Clinical Response - TOC
Tonsillopharyngitis
Drug Resistant Streptococcus pneumoniae
Telithromycin - PRSP CAP *
Telithromycin - ERSP CAP*
April 2001 - Efficacy Summary
Telithromycin- Phase 3 Safety Data
Deaths
Serious AEs - Phase 3
AEs - Phase 3
Telithromycin - April 2001 Advisory Focus on Safety
QTc effects: in vitro and preclinical data
?QTc with telithromycin: Phase 1
CYP3A4 inhibitor interactions
Telithromycin - Concentration Variation
Telithromycin pharmacokinetics in special populations
QTc: Phase 3
Telithromycin - Hepatic Data
Telithromycin - Hepatic Data
Telithromycin - Visual Data
April 2001 AC- Safety Summary
PPT Slide
Telithromycin - April 2001 AC Vote
April 2001 AC Recommendations
Telithromycin - June 2001 Action Letter
Telithromycin NDA Amendment - New Studies
Telithromycin NDA Amendment - New Studies
Telithromycin NDA Amendment- New Studies
Telithromycin NDA Amendment- New Studies
Telithromycin NDA Amendment- New Studies
Telithromycin NDA Amendment - Additional Data
In the Best Interest of the Public
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