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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Iobenguane I 131
Trade Name: Azedra Ultratrace
Date Designated: 01/18/2006
Orphan Designation: Treatment of neuroendocrine tumors
Orphan Designation Status: Designated/Approved
Progenics Pharmaceuticals, Inc.
One World Trade Center.
47th Floor, Suite J
New York, New York 10007
United States

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

Marketing approved:

1 Generic Name: Iobenguane I 131
Trade Name: Azedra Ultratrace
Marketing Approval Date: 07/30/2018
Approved Labeled Indication: AZEDRA is indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.
Exclusivity End Date: 07/30/2025 
Exclusivity Protected Indication* :  AZEDRA is indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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