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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: copper Cu 64 dotatate
Trade Name: Detectnet
Date Designated: 05/18/2016
Orphan Designation: Diagnostic for the management of neuroendocrine tumors.
Orphan Designation Status: Designated/Approved
RadioMedix Inc.
9701 Richmond Avenue, Suite 222
Houston, Texas 77042
United States

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

Marketing approved:

1 Generic Name: copper Cu 64 dotatate
Trade Name: Detectnet
Marketing Approval Date: 09/03/2020
Approved Labeled Indication: indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients
Exclusivity End Date: 09/03/2027 
Exclusivity Protected Indication* :  indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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