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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Recombinant human superoxide dismutase
Date Designated: 04/18/1991
Orphan Designation: Prevention of bronchopulmonary dysplasia in premature neonates weighing less than 1500 grams.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Savient Pharmaceuticals, Inc.
One Tower Center Boulevard, 12th floor
East Brunswick, New Jersey 08816
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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