FDA Approves New Formulation of Novartis’ Jadenu
Novartis has received approval from the US Food and Drug Administration (FDA) for Jadenu (deferasirox) tablets, a new oral formulation of Exjade (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients two years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older. Jadenu is the only once-daily oral iron chelator that can be swallowed whole.
Jadenu contains deferasirox, the same active ingredient that is in Novartis’ Exjade, a medicine that has been used for treating chronic iron overload for almost 10 years. Novartis has submitted additional regulatory applications for Jadenu in other countries worldwide.