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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: dinutuximab
Trade Name: Unituxin
Date Designated: 12/20/2010
Orphan Designation: Treatment of neuroblastoma
Orphan Designation Status: Designated/Approved
United Therapeutics Corporation
55 TW Alexander Drive
Research Triangle Park, North Carolina 27709
United States

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

Marketing approved:

1 Generic Name: dinutuximab
Trade Name: Unituxin
Marketing Approval Date: 03/10/2015
Approved Labeled Indication: For use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy
Exclusivity End Date: 03/10/2022 
Exclusivity Protected Indication* :  For use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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