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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: mouse-human chimeric monoclonal anti-GD2 IgG1 antibody
Date Designated: 09/20/2012
Orphan Designation: Treatment of neuroblastoma.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
EUSA Pharma (UK) Limited
Breakspear Park
Breakspear Way, England
United Kingdom

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.