FDAnews
www.fdanews.com/articles/82214-exjade-receives-first-approval-in-the-u-s

EXJADE RECEIVES FIRST APPROVAL IN THE U.S.

November 4, 2005

Novartis announced today the first approval worldwide for Exjade (deferasirox) -- a once-daily oral iron chelator -- by the FDA. Exjade has been approved for the treatment of chronic iron overload due to blood transfusions in adults and children age two and older.

Exjade is the only iron chelator administered as a drink (the tablets are dispersed in a glass of orange juice, apple juice or water), compared to the current standard of care, which often requires a subcutaneous infusion lasting eight to 12 hours per night, for five to seven nights a week for as long as the patient continues to receive blood transfusions or has excess iron within the body. As a result, many patients may have stopped or avoided iron chelation therapy, thus risking the toxic effects of iron overload.