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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: 02/24/2015
Orphan Designation: Treatment of chronic iron overload in alpha-thalassemia
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, New Jersey 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: 01/23/2013
Approved Labeled Indication: Treatment of chronic iron overload in patients 10 years of age and older with non-transfusion dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and serum ferritin greater than 300 mcg/L.
Exclusivity End Date: 01/23/2020 
Exclusivity Protected Indication* :  Treatment of chronic iron overload in patients 10 years of age and older with non-transfusion dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and serum ferritin greater than 300 mcg/L.
2 Generic Name: deferasirox
Trade Name: Exjade; Jadenu Sprinkles
Marketing Approval Date: 05/18/2017
Approved Labeled Indication: Treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L.
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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