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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Dihydrotestosterone
Date Designated: 02/05/1996
Orphan Designation: Treatment of weight loss in AIDS patients with HIV-associated wasting.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Besins Internaitonal, US Inc.
610 Herndon Parkway
Suite 750
Herndon, Virginia 20170
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.