FDA approves new formulation of Novartis' iron overload product

The US Food and Drug Administration has approved Jadenu (deferasirox), manufactured by Swiss drug major Novartis (NOVN: VX).

It is a new oral formulation of Exjade (deferasirox) tablets for oral suspension, and treats chronic iron overload due to blood transfusions in patients aged two years and over, and chronic iron overload in non-transfusion-dependent thalassemia syndromes in patients 10 years of age and older.

Although Jadenu is the only once-daily oral iron chelator that can be swallowed whole, the drug contains deferasirox, the same active ingredient as Exjade, which has been used by patients with chronic iron overload for almost a decade, and currently the most-prescribed chelator in the USA.