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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: IgG1 chimeric monoclonal antibody
Date Designated: 06/22/2011
Orphan Designation: Treatment of multiple myeloma.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
HaemaLogiX Pty Ltd.
Cicada Innovations, Suite 145
4 Cornwallis Street
Eveleigh NSW 2015

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.