Food and Drug Administration
Center for Drug Evaluation and Research
Cardiovascular and Renal Drugs Advisory Committee
97th Meeting
July 18, 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
A.M. Session
8:15 NDA 20-838/S015, ATACANDâ (candesartan cilexetil) Tablets,
AstraZeneca LP, for a proposed claim of comparative efficacy of candesartan cilexetil and losartan in hypertension.
Sponsor’s Presentation
Regulatory Introduction Cindy M. Lancaster, MS, MBA, JD
AstraZeneca
Comparison of the Antihypertensive Vasilios Papademetriou, MD, DSc,
Efficacy of Candesartan Cilexetil and FACC
Losartan Georgetown University
Epidemiologic and Clinical Significance William B. Kannell, MD, MPH,
of Incremental Changes in FACP, FACC
Blood Pressure Boston University School of Medicine
Summary Cindy M. Lancaster, MS, MBA, JD
9:15 Committee Discussion and Review
Committee Reviewer: Paul Armstrong, MD
10:00 Break
10:15 Open Public Hearing
10:45 Continuation of Committee Discussion and Review
12:00 Lunch
Cardiovascular and Renal Drugs Advisory Committee
97th Meeting
July 18, 2002
AGENDA (cont.)
P.M. Session
1:00 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
1:15 NDA 21-387, Pravastatin/Aspirin Combination Product, Bristol-Myers Squibb Company (BMS), proposed for long-term management to reduce the risk of cardiovascular events (death, nonfatal myocardial infarction, myocardial revascularization procedures, and ischemic stroke) in patients with clinically evident coronary heart disease.
Sponsor’s Presentation
Introductory Remarks Todd Baumgartner, MD
Vice President – Regulatory Sciences,
Life Cycle Management, BMS
Pravastatin/Aspirin: Safety and Rene Belder, MD
Dosing Considerations Executive Director – Clinical Design
and Evaluation, Metabolics, BMS
Summary Overview Fred Fiedorek, MD
Vice President – Clinical Design and
Evaluation and Exploratory Development,
BMS
2:15 Committee Discussion and Review
Committee Reviewer: Beverly Lorell, MD
3:00 Break
3:15 Open Public Hearing
3:45 Continuation of Committee Discussion and Review
5:00 Adjourn
Cardiovascular and Renal Drugs Advisory Committee
97th Meeting
July 18, 2002
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