Food and Drug Administration

Center for Drug Evaluation and Research

Cardiovascular and Renal Drugs Advisory Committee

97th Meeting

July 19, 2002

Holiday Inn, 8120 Wisconsin Avenue, Bethesda, MD

AGENDA

8:00 Call to Order and Opening Remarks Jeffrey Borer, MD, Chair

Introduction of Committee

Conflict of Interest Statement Jayne E. Peterson, RPh, JD,
Acting Executive Secretary, FDA

8:15 NDA 21-188, VANLEVÔ (omapatrilat), Bristol-Myers Squibb Company, proposed for
the treatment of hypertension.

Sponsorís Presentation

Introduction Anthony Waclawski, PhD
Director, Global Regulatory Sciences,
Pharmaceutical Research Institute,
Bristol-Myers Squibb Company

Clinical Efficacy Data Elliott Levy, MD
Vice President, Clinical Development,
Pharmaceutical Research Institute,
Bristol-Myers Squibb Company

Angioedema: Clinical Overview Allen Kaplan, MD
Professor, Department of Medicine,
Medical University of South Carolina,
Charleston, South Carolina

Clinical Safety Data Elliott Levy, MD

Benefit/Risk Considerations Charles H. Hennekens, MD
Professor of Medicine & Epidemiology/Public Health
University of Miami School of Medicine

Clinicianís Perspective Henry Black, MD
Chairman, Department of Preventative
Medicine, Professor of Internal Medicine,
Rush Medical College, Rush University
Chicago, Illinois

Conclusion Anthony Waclawski, PhD

Cardiovascular and Renal Drugs Advisory Committee

97th Meeting

July 19, 2002

Holiday Inn, 8120 Wisconsin Avenue, Bethesda, MD

AGENDA (cont.)

 

9:15 Committee Discussion and Review
Committee Reviewer: Steven Nissen, MD

10:00 Break

10:15 Open Public Hearing

10:45 Continuation of Committee Discussion and Review

12:00 Lunch

1:00 Continuation of Committee Discussion and Review

3:00 Adjourn

 

 

 

Meeting Guest (non-voting)

Thomas G. Pickering, MD, DPhil
Professor of Medicine
Director, Integrative and Behavioral Cardiovascular Health Program
and Hypertension Section

Michael and Zena A. Wiener Cardiovascular Institute
Mount Sinai School of Medicine
One Gustave L. Levy Place
New York, New York 10029-6574