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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tislelizumab
Date Designated: 05/14/2020
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
BeiGene USA, Inc.
1840 Gateway Dr, 3rd Floor
San Mateo, California 94404
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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