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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Orphan Designation Status: Designated/Withdrawn
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 Jan. 1, 2013, to the present.
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