Food and Drug Administration

Cardiovascular and Renal Drug Advisory Committee

September 10, 2004



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.

Introduction, Dr. Hamish Cameron, MD, AstraZeneca (PDF)

Ximelagatran Clinical Pharmacology, Dr. Troy Sarich, PhD, AstraZeneca (PDF)

Ximelagatran Efficacy, Dr. Jay Horrow, MD, MS, AstraZeneca (PDF)

Safety, Dr. Sunita Sheth, MD, FAHA, AstraZeneca (PDF)

Benefit and Risk of Anticoagulation - Oral Direct Thrombin Inhibition With Ximelagatran, Dr. Johaaathan Halperin, MD, Mount Sinai Medical Center, NY (PDF)