Food and Drug Administration

Endocrinologoc and Metabolic Drugs Advisory Committee

July 9, 2003


Crestor® (rosuvastatin calcium) Tablets


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Crestor® Introduction and Regulatory Overview, Mark Eliason, MSc, AstraZeneca (HTM) (PPT)

Crestor® Clinical Development Efficacy, Dr. James Blasetto, MD, MPH, AstraZeneca (HTM) (PPT)

Crestor® Safety, Dr. Howard Hutchinson, MD, AstraZeneca (HTM) (PPT)

Role of Rosuvastatin in the Treatment of Dyslipidemia, Dr. Daniel Rader, MD, AstraZeneca (HTM) (PPT)

Backup Material, AstraZeneca (HTM) (PPT)

Crestor® (ZD4522, rosuvastatin calcium) Tablets - Comments on Efficacy, Joy Mele, FDA (HTM) (PPT)

Issues to be Addressed by the Advisory Committee, FDA (HTM) (PPT)

Open Public Hearing

Statement of Dr. Sidney Wolfe, MD, Public Citizen's Health Research Group (PDF)