Food and Drug Administration

Anti-Infective Drugs Advisory Committee

January 7, 2003



The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Ketek™ (telitihromycin) NDA Background, Dr. Janice Soreth, MD, FDA (HTM) (PPT)

Macrolide-Resistant Streptococcus Pneumoniae: What is the Public Health Impact?, Dr John Powers, MD, FDA (HTM) (PPT)

Ketek™ (telithromycin) Introduction, Dr. Steve Caffe, MD, Aventis Pharmaceuticals (HTM) (PPT)

Back-up Information, Aventis Pharmaceuticals (HTM) (PPT)

Ketek™ (telithromycin) NDA 21-144 Efficacy Review, Dr. John Alexander, MD, MPH, FDA (HTM) (PPT)

Telithromycin Integrated Summary of Safety, Dr. Charles Cooper, MD, FDA (HTM) (PPT)

Large Comparative Safety Trial in an Usual Care Setting (HTM) (PPT)

Patient 502/1069, Dr. David Kleiner, MD, PhD, FDA (HTM) (PPT)

Post-Marketing Safety Data, Dr. Charles Cooper, MD, FDA (HTM) (PPT)