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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: humanized, bispecific IgG1-like antibody directed against HER2
Date Designated: 12/18/2019
Orphan Designation: Treatment of Biliary Tract Cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Zymeworks Inc.
1385 West 8th Street, Suite 540
Vancouver, BC V6H 3V9

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.