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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 123
Trade Name: AdreView
Date Designated: 12/01/2006
Orphan Designation: For the diagnosis of pheochromocytomas
Orphan Designation Status: Designated/Approved
GE Healthcare, Inc.
101 Carnegie Center
Princeton, New Jersey 08540
United States

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

Marketing approved:

1 Generic Name: Iobenguane I 123
Trade Name: AdreView
Marketing Approval Date: 09/19/2008
Approved Labeled Indication: To be used in the detection of primary or metastatic pheochromocytomas or neuroblastomas as an adjunct to other diagnostic tests
Exclusivity End Date: 09/19/2015 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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