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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Superoxide dismutase (human)
Date Designated: 03/06/1985
Orphan Designation: For protection of donor organ tissue from damage or injury mediated by oxygen-derived free radicals that are generated during the necessary periods of ischemia (hypoxia, anoxia), and especially reperfusion, associated with the operative procedure.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pharmacia-Chiron Partnership
4560 Horton Street
Emeryville, California 94608
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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