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U.S. Department of Health and Human Services

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Trastuzumab Product Approval Information - Licensing Action 9/25/98

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)

Label (PDF) (oversize document; if printing, use 'shrink to fit')

Review Documents

Biopotency Review (PDF)

Clinical Review

CMC Review (PDF)

Pharmacology Review (PDF)

Statistical Review (PDF)