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Herceptin FDA Approval History

FDA Approved: Yes (First approved September 25, 1998)
Brand name: Herceptin
Generic name: trastuzumab
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Breast Cancer, Gastric Cancer

Herceptin (trastuzumab) is a HER2/neu receptor antagonist indicated for the treatment of HER2 overexpressing breast cancer and for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Development Timeline for Herceptin

Oct 20, 2010Approval  FDA Approves Herceptin For HER2-Positive Metastatic Stomach Cancer
Nov 16, 2006Approval  FDA Approves Herceptin for the Adjuvant Treatment of HER2-Positive Node-Positive Breast Cancer
Sep 25, 1998Approval  Herceptin: Biotechnology Breakthrough In Breast Cancer Wins FDA Approval

Further information

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