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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Anti-HER2 bispecific antibody
Date Designated: 02/06/2017
Orphan Designation: Treatment of gastric cancer, including cancer of the gastroesophageal junction
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Jazz Pharmaceuticals Ireland Limited
3170 Porter Drive
Palo Alto, California 94304
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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