CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE

94th Meeting

AGENDA

National Institutes of Health

Building 10, Clinical Center, Jack Masur Auditorium

9000 Rockville Pike

Bethesda, MD.

Thursday, October 11, 2001

9:00 a.m. Call to Order Jeffrey Borer, M.D., Acting Chair

Conflict of Interest Statement Joan C. Standaert, Executive Secretary

Open Public Hearing Scientific presentation will begin once the last open public hearing participant has spoken.

10:00 a.m. NDA 20-665/S-016 and NDA 21-283/S-001, Diovanâ (valsartan), Novartis

Pharmaceuticals Corporation, for the treatment of patients with heart failure

Novartis Presentations

Introduction Mathias Hukkelhoven, Ph.D.

Vice-President, Regulatory Affairs

Novartis Pharmaceuticals Corp.

Clinical Efficacy Data/ Jay N. Cohn, M.D.

Efficacy Subgroup Analyses Professor of Medicine

University of Minnesota Medical School

Val-HeFT Study Chairman

Safety Data Robert Glazer, M.D.

Director, Cardiovascular Clinical

Research

Novartis Pharmaceuticals Corp.

Benefit:Risk Discussion Jay N. Cohn, M.D.

11:15 a.m. Committee Discussion

Committee Reviewer Thomas Fleming, Ph.D.

Professor and Chair

University of Washington

12:00 p.m. Lunch

12:45 p.m. Committee Review and Discussion/Recommendations

3:00 p.m. Adjourn