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Trastuzumab
Product Approval Information - Licensing Action
Proper name: Trastuzumab
Tradename: Herceptin
Manufacturer: Genentech, Inc, South San Francisco, CA, License #1048
Indication for Use: Treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease. Trastuzumab in combination with paclitaxel is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress HER2 protein and who have not received chemotherapy for their metastatic disease
Approval Date: 9/25/98
Type of submission: Biologics license application
Approval Letter
(PDF),
(Text)
Label (PDF)(oversize document; if printing, use 'shrink to fit')
Review Documents
Biopotency Review (PDF)
Clinical Review (Part 1 - PDF), (Part 2 - PDF)
CMC Review (PDF)
Pharmacology Review (PDF)
Statistical Review (PDF)
Talk Paper
Last Updated: 3/6/2001
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Updated: September 25, 2003 |
