Food and Drug Administration

Anti-Infective Drugs Advisory Committee

January 8, 2003

Briefing Information


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™ (telithromycin), Aventis Pharma (PDF)

New Drug Application (NDA) 21-144 Ketek™ (telithromycin) Cover Sheet, FDA (HTM) (PDF) (Word)

New Drug Application (NDA) 21-144 Ketek™ (telithromycin) FDA Review, FDA (HTM) (PDF) (Word)

Appendix A (HTM) (PDF) (Word)

Appendix B (HTM) (PDF) (Word)

Appendix C (PDF)

Appendix D (PDF)

Appendix E (HTM) (PDF) (Word)