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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: guanfacine
Date Designated: 08/05/1999
Orphan Designation: Treatment of fragile X syndrome.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Watson Laboratories, Inc.
311 Bonnie Circle
P.O. Box 1900
Corona, California 91718
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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