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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: EnGeneIC delivery vehicles loaded with doxorubicin and targeted to tumor with sequences from Vectibix and mouse monoclonal antibody
Date Designated: 02/14/2017
Orphan Designation: Treatment glioblastoma multiforme
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
EnGeneIC Ltd
25 Sirius Road
Building 2
Lane Cove West, New South Wales

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.