Search Orphan Drug Designations and Approvals
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| Generic Name: | trastuzumab | ||||||||||||||||
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| 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 | ||||||||||||||||
| Sponsor: |
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. |
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Marketing approved: |
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| 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* : | ||
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