FOOD
AND DRUG ADMINISTRATION
CENTER
FOR DRUG EVALUATION AND RESEARCH (CDER)
Endocrinologic and Metabolic Drugs Advisory
Committee Meeting
CRESTOR®
Indicated for the treatment
of hypercholesterolemia and mixed dyslipidemia
Clinical Review, CRESTOR®
(ZD4522, rosuvastatin calcium) Tablets
(HTM) (PDF)
(Word)
Clinical Review Appendix Subsection
6.1
MedWatch Forms for Cases of
Special Interest
CRESTOR® (ZD4522,
rosuvastatin calcium) Tablets
Statistical Review and
Evaluation Clinical Studies #1
CRESTOR® (rosuvastatin
calcium) Tablets
Statistical Review and
Evaluation Clinical Studies #2
CRESTOR® (rosuvastatin
calcium) Tablets
Pharmacology/Toxicology
Review
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.