Search Orphan Drug Designations and Approvals
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| Generic Name: | dinutuximab | ||||||||||||||||
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| Trade Name: | Unituxin | ||||||||||||||||
| Date Designated: | 12/20/2010 | ||||||||||||||||
| Orphan Designation: | Treatment of neuroblastoma | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
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. |
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Marketing approved: |
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| 1 | Generic Name: | dinutuximab |
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| 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 | |
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