Novartis announced that the Food and Drug Administration (FDA) has approved Jadenu (deferasirox) tablets for the treatment of chronic iron overload due to blood transfusions in patients ≥2 years old, and for chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients ≥10 years old. 

Jadenu is the new oral formulation of Novartis’ Exjade (deferasirox) tablets for oral suspension. Deferasirox is an orally-active chelator that is selective for iron (as Fe3+). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Although deferasirox has very low affinity for zinc and copper there are variable decreases in the serum concentration of these trace metals after the administration of deferasirox.

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Jadenu was approved under accelerated approval based on data demonstrating the reduction of liver iron concentrations and serum ferritin levels. It will be available as an oral, film-coated tablet in 90mg, 180mg, and 360mg strengths in 30-count bottles.

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