Arthritis Advisory Committee

November 29, 2006

Slides

The Committee discussed the safety and efficacy of the nonsteriodal anti-inflammatory drug (COX-2 inhibitor) new drug application (NDA) 20-998/S021, CELEBREX (celecoxib), Pfizer, Inc., for the proposed indication of the relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years and older.

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FDA Presentation

Introduction of Juvenile, Rheumatoid Arthritis & State of the Art Treatment Armamentarium, Carolyn Yancey, M.D., Medical Officer, DAARP, CDER, FDA (PPT) (HTM)

Cardiovascular Risk and NSAIDS, Sharon Hertz, M.D., Deputy Director, DAARP, CDER, FDA (PPT) (HTM)

Risk/Benefit Profile of Celebrex for Use in JRA, Jeffrey Siegel, M.D., Medical Team Leader, DAARP, CDER, FDA (PPT) (HTM)

Sponsor Presentation

Juvenile Rheumatoid Arthritis: Clinical Overview, Daniel J. Lovell, M.D., MPH, Cincinnati Children's Hospital Medical Center (PPT) (HTM)

Celecoxib in the Treatment of Juvenile Rheumatoid Arthritis, Simon Lowery, M.D., Pfizer, Inc (PPT) (HTM)

Open Public Hearing

A Survey of Pediatric Rheumatologists to Determine Usage and Experience with Celebrex, Gloria Higgins, PhD, MD, Associate Professor of Pediatrics, The Ohio State University, Division of Rheumatology, Columbus Children's Hospital (PPT) (HTM)

Coxib 2005 Survey, Brandt Groh, MD, Penn State Children's Hospital, Division of Pediatric Rheumatology, Allergy and Immunology (PPT) (HTM)

Cox-2 vs. Other NSAID Use in Children with JRA, Kathleen A. Haines, MD, Section Chief, Pediatric Immunology, Section of Pediatric Rheumatology and Immunology, Hachensack University Medical Center, Hackensack, NJ (PPT) (HTM)

Questions from the Committee (PPT) (HTM)

Questions to the AAC and AAC Discussion (PPT) (HTM)

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