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

 

AGENDA

 

 

 

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

Chair, Endocrinologic and Metabolic Drugs Advisory Committee, EMDAC

 

                        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

 

 

9:00 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 Professor of Medicine

                                                                                    University of Pennsylvania

 

10:30 a.m.         Break

 

10:45 a.m.         Questions from the Committee

 

 

11:15 a.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 p.m.        Questions from the Committee

 

12:30 p.m.        Lunch

 

 1:30 p.m.         Open Public Hearing

 

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

 

 

 2:45 p.m.         Committee Discussions/Questions

 

 3:30 p.m.         Break

 

 3:45 p.m.         Committee Discussions/Questions/Summary

 

 5:00 p.m.         Adjournment