Food and Drug
Administration
Arthritis Advisory Committee
April 12, 2007
The committee discussed new drug application (NDA) 21-389/21-772, ARCOXIA (etoricoxib), Merck & Co., Inc., proposed treatment for the relief of signs and symptoms of osteoarthritis.
Slides
FDA Presentation
History of Cardiovascular Findings from NSAID studies, Sharon Hertz, M.D., Deputy Director DAARP, CDER, FDA (PPT) (HTM)
Medical Review: Etoricoxib Application, Robert Shibuya, M.D., Medical Officer, DAARP, CDER, FDA (PPT) (HTM)
An Epidemiologic Perspective on Etoricoxib, Office of Surveillance and Epidemiology, David J. Graham, M.D., CDER, FDA (PPT) (HTM)
Sponsor Presentation
Osteoarthritis: Disease Burden and Unmet Patient Needs, Grant W. Cannon, M.D. Division of Rheumatology, University of Utah (PDF)
Efficacy and Safety Summary, Sean Curtis, M.D. Executive Director, Clinical Research, Merck Research Laboratories (MRL), core and backup slides (PDF)
Open Public Hearing Speakers
David Egilman, M.D., MPH, Clinical Associate Professor, Brown University (PPT) (HTM)
Sid Wolfe, M.D., Director Public Citizen Health Research Group (PPT) (HTM)
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