FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Endocrinologic and Metabolic Drugs Advisory Committee Meeting

July 9, 2003

Briefing Information

CRESTOR^®

Indicated for the treatment of hypercholesterolemia and mixed dyslipidemia

FDA Background Package

Clinical Review, CRESTOR^® (ZD4522, rosuvastatin calcium) Tablets
(HTM) (PDF) (Word)

Clinical Review Appendix Subsection 6.1 (HTM) (PDF) (Word)

MedWatch Forms for Cases of Special Interest

CRESTOR^® (ZD4522, rosuvastatin calcium) Tablets (PDF)

Statistical Review and Evaluation Clinical Studies #1

CRESTOR^® (rosuvastatin calcium) Tablets (HTM) (PDF) (Word)

Statistical Review and Evaluation Clinical Studies #2

CRESTOR^® (rosuvastatin calcium) Tablets (PDF)

Pharmacology/Toxicology Review

CRESTOR^® (rosuvastatin calcium) Tablets (HTM) (PDF) (Word)

Disclaimer

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.

Astra Zeneca Background Package

CRESTOR^® (rosuvastatin calcium) Tablets

NDA 21-366 (PDF)