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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
Date Designated: 12/14/1999
Orphan Designation: Treatment of patients with pancreatic cancer that overexpress p185HER2.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Genentech, 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 Jan. 1, 2013, to the present.
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