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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Dehydroepiandrosterone
Date Designated: 07/13/1994
Orphan Designation: Treatment of systemic lupus erythematosus (SLE) and the reduction in the use of steroids in steroid-dependent SLE patients.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
GlaxoSmithKline
P. O. Box 13398
Five Moore Drive
Research Triangle Park, North Carolina 27709
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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