Food and Drug Administration

Blood Products Advisory Committee

September 29, 2005

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.

Novartis Briefing Document

Exjade® (deferasirox; ICL670) Tablets for ORal Suspension NDA 21-882 (PDF)


FDA Briefing Document

Exjade (ICL 670, deferasirox) Summary - Introduction and Background (PDF)

Clinical Review (PDF)

Pharmacology/Toxicology Review and Evaluation (PDF)

Draft Clinical Pharmacology and Biopharmaceutics Executive Summary (PDF)

Statistical Review and Evaluation (PDF)

Preliminary Review on BLS Using the SQUID Magnetometer Under NDA 21882 (PDF)

Errata Sheet to the FDA Background Document (PDF)