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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 and amphetamine
Date Designated: 03/17/2016
Orphan Designation: Treatment of pediatric patients with Tourette's syndrome (0 through 16 years of age)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
KemPharm, Inc.
1180 Celebration Boulevard
Suite 103
Celebration, Florida 34747
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.