Ketek? (telithromycin) NDA Background

1/14/03


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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

Author: CDER USER