FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Endocrinologic and Metabolic Drugs Advisory Committee Meeting

July 9, 2003

Holiday Inn, Versailles Ballroom, Bethesda, MD

DRAFT AGENDA

8:30 a.m. Call to Order and Introductions Glenn Braunstein, M.D.

Chair, Endocrinologic and Metabolic Drugs Advisory Committee

Conflict of Interest Statement Dornette Spell-LeSane, M.H.A., NP-C

Executive Secretary, EMDAC

8:45 a.m. Welcome and Introductory Comments David Orloff, M.D.

Director

Division of Metabolic and Endocrine

Drug Products, FDA

__________________________________________________________________________________________

NDA 21-366 Crestor® (rosuvastatin calcium) tablets, AstraZeneca Pharmaceuticals agent for

iPR Pharmaceuticals, Inc.

Proposed for the indication of treatment of hypercholesterolemia and mixed dyslipidemia

9:15 a.m. Sponsor Presentation

Introduction and Mark S. Eliason, M.Sc.

Regulatory Overview Director, Regulatory Affairs

AstraZeneca

Clinical Development James W. Blasetto, M.D., M.P.H.

Efficacy Overview Senior Medical Director

AstraZeneca

Clinical Development Howard G. Hutchinson, M.D.

Safety Overview Vice President, Clinical Research

AstraZeneca

Endocrinologic and Metabolic Drugs Advisory Committee

Meeting

July 9, 2003

Agenda (cont.)

Sponsor Presentation Cont.

The Role of Rosuvastatin in the Daniel J. Rader, M.D.

Treatment of Hyperlipidemia Associate Program Director

University of Pennsylvania

10:30 – 10:45 a.m. Break

10:45 – 11:15 a.m. Committee Discussions

11:15a.m. FDA Presentation

Efficacy Joy Mele, M.S.

Statistical Reviewer

Division of Biometrics II

Office of Biostatistics, FDA

Safety and Dosing William Lubas, M.D.

Medical Officer

Division of Metabolic and Endocrine

Drug Products, FDA

11:45 – 12:30 p.m. Questions from the Committee

12:30 – 1:30 p.m. Lunch

1:30 – 2:30 p.m. Open Public Hearing

2:30 – 2:45p.m. Charge to the Committee David Orloff, M.D.

Director

Division of Metabolic and Endocrine

Drug Products, FDA

2:45 – 3:30 p.m. Committee Discussions/Questions

3:30 – 3:45 p.m. Break

3:45 – 4:45 p.m. Committee Discussions/Questions/Review

5:00 p.m. Adjournment