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 20-838/S015, ATACANDâ (candesartan cilexetil) Tablets,
AstraZeneca LP, for a proposed claim of comparative efficacy of candesartan cilexetil and losartan in hypertension.

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

1:00 Call to Order and Opening Remarks Jeffrey Borer, MD, Chair

Introduction of Committee

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.

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

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