Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Cardiovascular and Renal Drugs Advisory Committee

98th Meeting

January 6, 2003

Holiday Inn, 8777 Georgia Avenue, Silver Spring, MD

AGENDA

8:30 Call to Order and Opening Remarks Jeffrey Borer, M.D., Chair

Introduction of Committee

Conflict of Interest Statement Jayne E. Peterson, R.Ph., J.D., Acting Executive Secretary, FDA

______________________________________________________________________

sNDA 20-386/S-032 Cozaarâ (losartan potassium) Tablets, Merck and Co.

Proposed for the reduction in the risk of cardiovascular morbidity and mortality as

measured by the combined incidence of cardiovascular death, stroke and myocardial

infarction in hypertensive patients with left ventricular hypertrophy.

8: 45 Sponsor Presentation

Introduction
Jeffrey R. Tucker, M.D.


Director, Regulatory Affairs


Merck Research Laboratories

The LIFE Study: Background, Rationale and Results
Jonathan M. Edelmann, M.D.
Senior Director, Clinical Development
Merck U.S. Human Health Division

Review of the Evidence and Conclusions
William F. Keane, M.D.
Vice President, Clinical Development
Merck U.S. Human Health Division

10:15 Break

10:30 FDA Presentation

Ethnic Subgroup Analysis from the LIFE Study
John Lawrence, Ph.D.
Mathematical Statistician, FDA

 

Cardiovascular and Renal Drugs Advisory Committee

98th Meeting

January 6, 2003

 

AGENDA (cont.)

 

11:00 Committee Discussion and Review

Committee Reviewer: Thomas Fleming, Ph.D.

12:00 Lunch

1:00 Open Public Hearing

2:00 Continuation of Committee Discussion and Review

3:00 Break

3:15 Continuation of Committee Discussion and Review

5:00 Estimated Time of Adjournment

 

 

 

SGE Consultant (voting)

Thomas G. Pickering, M.D., 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

Acting Industry Representative (non-voting)

John Neylan, M.D.
Vice President, Clinical Research and Development
Wyeth Research
500 Ariola Road
Collegeville, Pennsylvania 19426