CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE

96^th Meeting

April 12, 2002

Holiday Inn, Silver Spring, MD

AGENDA

NDA 20-386/S028, Cozaar™ (losartan potassium), Merck and Company, Inc.

Proposed Indication: for the treatment of type II diabetic patients with nephropathy

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

8:35 Conflict of Interest Statement Jayne E. Peterson, R.Ph., J.D., Acting Executive Secretary

8:40 NDA 20-386/S028, Cozaar™ (losartan potassium), Merck and Company, Inc., for the treatment of type II diabetic patients with nephropathy.

Sponsor’s Presentation

Introduction Michael C. Elia, Ph.D.

Director, Regulatory Affairs

Merck Research Laboratories

Background, Rationale and Results of Shahnaz Shahinfar, M.D.

the RENAAL Study Senior Director,

Cardiovascular Clinical Research

Merck Research Laboratories

Review of the Evidence and Conclusions William Keane, M.D.

Vice President, Clinical Development

Merck – US Human Health Division

9:45 Break

10:00 Committee Discussion and Review

Committee Reviewer: JoAnn Lindenfeld, M.D.

12:00 Lunch

1:00 Open Public Hearing

2:00 Committee Discussion and Review (continuation)

3:00 Break

4:30 Adjourn