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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Orgotein for injection
Date Designated: 12/22/1994
Orphan Designation: Treatment of familial amyotrophic lateral sclerosis associated with a mutation of the gene (on chromosome 21q) for copper, zinc superoxide dismutase.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Oxis International, Inc.
6040 N. Cutter Circle, Suite 317
Portland, Oregon 97217
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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