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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
Trade Name: Herceptin
Date Designated: 10/13/2009
Orphan Designation: Treatment of HER2-overexpressing advanced adenocarcinoma of the stomach, including gastroesophageal junction
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: trastuzumab
Trade Name: Herceptin
Marketing Approval Date: 10/20/2010
Approved Labeled Indication: Treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease
Exclusivity End Date: 10/20/2017 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.