Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

July 18, 2002

Morning Session

NDA 20-838/S-015 ATACAND® (candesartan cilexetil)


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.

Background Information, AstraZeneca LP   pdf

Food and Drug Administration Briefing Information

Medical Review   pdf   htm   doc

Statistical Review and Evaluation  pdf   htm   doc

Clinical Pharmacology and Biopharmaceutics Review   pdf   htm   doc