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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tetra substituted prophyrin derivative containing manganese (III)
Date Designated: 01/17/2014
Orphan Designation: For use in patients exposed to radiation following a nuclear accident or detonation in order to treat or mitigate acute radiation syndrome.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Aeolus Pharmaceuticals, Inc.
26361 Crown Valley Parkway
Suite 150
Mission Viejo, California 92691
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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