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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 neuroblastomas
Orphan Designation Status:  Designated/Approved
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* :  
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.