Ketekô (Telithromycin) NDA 21-144 Efficacy Review

1/14/03


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Table of Contents

Ketekô (Telithromycin) NDA 21-144 Efficacy Review

Outline

Indications

Acute Exacerbation of Chronic Bronchitis

Acute Exacerbation of Chronic Bronchitis

Acute Exacerbation of Chronic Bronchitis

Acute Exacerbation of Chronic Bronchitis

Acute Sinusitis

Acute Sinusitis

Acute Sinusitis

Community-Acquired Pneumonia

Community-Acquired Pneumonia

Community-Acquired Pneumonia

Community-Acquired Pneumonia

Community-Acquired Pneumonia

Drug-Resistant S. pneumoniae

CAP: Drug-Resistant S. pneumoniae Telithromycin MIC

CAP: Drug-Resistant S. pneumoniae

CAP: Drug-Resistant S. pneumoniae

CAP: Drug-Resistant S. pneumoniae

CAP: Drug-Resistant S. pneumoniae

CAP: Drug-Resistant S. pneumoniae Bacteremia Patients

CAP: Drug-Resistant S. pneumoniae Cases from Japanese Studies

AS: Drug-Resistant S. pneumoniae

AS: Drug-Resistant S. pneumoniae

Acknowledgments

Author: FDA.CDER