Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

September 10, 2004

Briefing Information


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 Material - Exanta® (Ximelagatran) Tablets, AstraZenea (PDF)

FDA Background Material

Cover Letter (HTM) (PDF) (Word)

Integrated Executive Summary (HTM) (PDF) (Word)

Clinical Review - Exanta (Ximelagatran) Tablets (HTM) (PDF) (Word)

Statistical Review and Evaluation - Exanta (Ximelagatran) (HTM) (PDF) (Word)

Clinical Review - Ximelagatran (H376/95) (HTM) (PDF) (Word)

Statistical Review and Evaluation - Exanta (Ximelagatran) 36 mg bid oral formulation (HTM) (PDF) (Word)

Office of Drug Safety Review (HTM) (PDF) (Word)

Clinical White Paper (PDF)