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Anti-Infective Drugs Advisory Committee in Joint Session with the Drug Safety and Risk Management Advisory Committee

December 15, 2006

The Committee discussed the overall benefit to risk considerations for the approved product KETEK (telithromycin), new drug application (NDA) 21-144, with the current indications of: acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, and community acquired pneumonia, manufactured by Sanofi-Aventis.

Slides

FDA

Visual AE, Loss of Consciousness and Myasthenia Gravis Analyses of AERS Reports, Ronald Wassel, Pharm.D., Safety Evaluator, Office of Surveillance and Epidemiology, CDER, FDA (PPT) (HTM)

OSE Summary Considerations of Benefit and Risk, Rosemary Johann-Liang, M.D., Deputy Director, Division of Drug Risk Evaluation (OSE), CDER, FDA (PPT) (HTM)

Summary Comments & Charge to the Committee, Edward Cox, M.D., M.P.H., Acting Director, Office of Antimicrobial Products, CDER, FDA (PPT) (HTM

Sponsor Presentation

Adverse events of special interest: Exacerbations of Myasthenia Gravis, Syncope/loss of consciousness

Overview of Safety experience, Barbara Rullo, M.D., Therapeutic Area Head, GPE (Marketed Products) (PDF)

Expert review: visual, Randy Kardon, M.D., Associate Professor, Department of Ophthalmology and Visual Science, Neuro-ophthalmology Division, University of Iowa Hospital and Clinics, Iowa City, IA (PDF)

Expert review myasthenia gravis, Donald Sanders, M.D., Co-Director EMG Laboratory, Duke University, Durham, NC (PDF)

Treatment options for respiratory tract infections, role of Telithromycin

Overview and CAP, Daniel Musher, M.D., Professor of Molecular Virology & Microbiology, Baylor College of Medicine, Chief of Infectious Diseases, Veterans Affairs Hospital, Houston, TX (PDF)

AECB-Etiology, Outcomes and Antibiotics, Sunjay Sethi, M.D., Associate Pprofessor, Department of medicine, University of Buffalo, State university of New York at Buffalo, NY (PDF)

Anti-Bacterials in ABS, Berrylin J. Ferguson, M.D., Associate Professor, Department of Otolaryngology, University of Pittsburg, Medical Center, Pittsburg, PA (PDF)

Summary and Conclusions, Bruno Leroy, M.D. Head, Internal Medicine, Franchise, Global Medical Affairs (PDF)

Open Public Hearing Speakers

David Ross, M.D., Ph.D., Mark P. Cohen representing the Government Accountability (PPT) (HTM)

Helen W. Boucher, M.D. representing the Antimicrobial Availability Task Force of the Infectious Diseases Society of America (PPT) (HTM)

John H. Powers III, MD, FACP (PPT) (HTM)

David Shlaes, M.D., Ph.D. of the Anti-infectives Consulting, LLC (PPT) (HTM)

Prabha Fernandes, Ph.D. of Cempra Pharmaceuticals Inc. (PPT) (HTM)

Questions (PDF)

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