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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: trastuzumab emtansine
Date Designated: 10/25/2013
Orphan Designation: For the treatment of gastric cancer including gastroesophageal junction cancer.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 05/12/2016
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Genethech, Inc.
1 DNA Way
south San Francisco, California 94080
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.