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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: aripiprazole
Trade Name: Abilify
Date Designated: 01/25/2006
Orphan Designation: Treatment of Tourette's syndrome
Orphan Designation Status: Designated/Approved
Otsuka Pharmaceutical Development
and Commercialization
1st Floor
Princeton, New Jersey 08540
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: aripiprazole
Trade Name: Abilify
Marketing Approval Date: 12/12/2014
Approved Labeled Indication: Treatment of pediatric patients with Tourette's
Exclusivity End Date: 12/12/2021 
Exclusivity Protected Indication* :  Treatment of pediatric patients with Tourette's
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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