Novartis Announces Approval of Jadenu

April 1, 2015 – 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 and older, and for chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years and older.

Jadenu is a new formulation of Exjade which is designed to be taken as a pill and swallowed, rather than dispersed in liquid to drink.

CAF had a phone call with Novartis on April 1 to discuss Jadenu, the new oral tablet formulation of deferasirox. To summarize:

  • Novartis anticipates that Jadenu will be available for pharmacies to order beginning on April 13th. Although it is possible that this date might change, April 13th is the current target date.
  • Some of the inactive ingredients that were present in Exjade are no longer present in the Jadenu formulation, including lactose and sodium lauryl sulfate.
  • Lower doses of Jadenu (90 mg, 180 mg, or 360 mg) are bio-equivalent to higher doses of Exjade (125 mg, 250 mg, or 500 mg).
  • Jadenu tablets may be taken on an empty stomach or with a light meal.
  • There is no data available yet which compares the safety and efficacy of Exjade and Jadenu, but results of a study now in progress will be completed in 2016.
  • Jadenu is currently approved only in the U.S.
  • We are waiting to hear from Novartis with regard to the pricing and co-pay assistance for Jadenu and will provide an update when this information becomes available.

Jadenu Prescribing Information is now available at:

A press release about this announcement can be accessed by clicking here.

Secured By miniOrange