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Advisory Committees

Food and Drug Administration

Joint meeting of the Anti-Infective Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

December 14 & 15, 2006

Briefing Information

Ketek (telithromycin) NDA 21-144

Food and Drug Administration

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space or . on the screen or on the printed page.

  • Briefing Document, Division of Anti-Infective and Ophthalmology Products (pdf)
  • Briefing Document, Division of Drug Risk Evaluation Office of Surveillance and Epidemiology (pdf)
    • Briefing Document, Division of Drug Risk Evaluation Office of Surveillance and Epidemiology, VONA Truffa 2006-715 table (pdf)

Sanofi-aventis

Disclaimer

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.

  • Briefing Material (Redacted) (htm)
  • Addendum (pdf)

Page updated: December 12, 2006