ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING

January 8, 2003

Marriott Washingtonian Center, Grand Ballroom, 9751 Washingtonian Blvd., Gaithersburg, MD

NDA 21-144, Ketek^™ (telithromycin), Aventis Pharmaceuticals, Inc., proposed for treatment of community-acquired pneumonia, acute exacerbation of chronic bronchitis, and acute maxillary sinusitis

8:00 a.m. Call to Order James E. Leggett, Jr., M.D.
Acting Chair, AIDAC

Introduction of Committee

Conflict of Interest Statement Tara P. Turner, Pharm.D.
Executive Secretary, AIDAC

8:10 a.m. Historical Background on Ketek^™ Submission Janice Soreth, M.D.
Director
Division of Anti-Infective Drug Products
FDA

8:30 a.m. Macrolide Resistance Joshua P. Metlay, M.D., Ph.D.
University of Pennsylvania
Center for Clinical Epidemiology
and Biostatistics

9:00 a.m. Sponsor Presentation Aventis Pharmaceuticals, Inc.

10:30 a.m. Break

10:45 a.m. FDA Presentation John Alexander, M.D., M.P.H.
Medical Team Leader
Division of Anti-Infective Drug Products

Chuck Cooper, M.D.
Medical Officer
Division of Anti-Infective Drug Products

C. George Rochester, Ph.D.
Statistician
Division of Biometrics III

David Kleiner, M.D., Ph.D.
Laboratory of Pathology
National Cancer Institute
National Institutes of Health

Chuck Cooper, M.D.

12:30 p.m. Lunch

1:30 p.m. Open Public Hearing

2:00 p.m. Committee Discussion and Vote

5:00 p.m. Adjourn