On Sept. 25, 1998, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody Herceptin (Trastuzumab) for treatment of metastatic breast cancer in patients with tumors that produce excess amounts of a protein called HER-2. Approximately 30% of breast cancer tumors produce excess amounts of HER-2.

Trastuzumab is indicated for 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. In accordance with approved labeling, your product will bear the tradename Herceptin and will be marketed in 440 mg multi-dose vials supplied with Bacteriostatic Water for Injection, USP (containing 1.1% benzyl alcohol).