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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Deferasirox
Trade Name: Exjade; Jadenu Sprinkles
Date Designated: 11/21/2002
Orphan Designation: Treatment of chronic iron overload in patients with transfusion-dependent anemias
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corp.
One Health Plaza
East Hanover, New Hampshire 07936
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Deferasirox
Trade Name: Exjade; Jadenu Sprinkles
Marketing Approval Date: 11/02/2005
Approved Labeled Indication: Treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age or older
Exclusivity End Date: 11/02/2012 
Exclusivity Protected Indication* :  
2 Generic Name: Deferasirox
Trade Name: Exjade; Jadenu Sprinkles
Marketing Approval Date: 05/18/2017
Approved Labeled Indication: treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older
Exclusivity End Date: N/A  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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