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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Cyproterone acetate
Date Designated: 10/26/1984
Orphan Designation: Treatment of severe hirsutism.
Orphan Designation Status: Designated/Withdrawn
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Berlex Laboratories, Inc.
300 Fairfield Road
Wayne, New Jersey 07470
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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