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Erbitux Approval History

  • FDA approved: Yes (First approved February 12th, 2004)
  • Brand name: Erbitux
  • Generic name: cetuximab
  • Dosage form: Injection
  • Company: ImClone
  • Treatment for: Colorectal Cancer, Head and Neck Cancer

Erbitux is epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of colorectal cancer and Head and Neck Cancer.

Development History and FDA Approval Process for Erbitux

DateArticle
Nov  7, 2011Approval FDA Approves Erbitux to Treat Late-stage Head and Neck Cancer
Dec  8, 2008Erbitux Supplemental Biologics License Application for Advanced Non-Small Cell Lung Cancer Submitted to U.S. Food and Drug Administration
Oct 31, 2008Erbitux Supplemental Biologics License Application for First-Line Recurrent or Metastatic Head and Neck Cancer Accepted for Priority Review by U.S. Food and Drug Administration
Sep  3, 2008ImClone Submits Supplemental Biologics License Application for Erbitux in First-Line Head and Neck Cancer
Sep  4, 2007Merck Applies to Extend Use of Erbitux for 1st-Line Colorectal Cancer
Jun 11, 2007FDA Accepts and Grants Priority Review of Erbitux (Cetuximab) sBLA for Overall Survival in Patients With Advanced Colorectal Cancer
Aug 30, 2005ImClone Systems Incorporated and Bristol-Myers Squibb File Supplemental Biologics License Application for Erbitux for Treatment of Head and Neck Cancer
Feb 12, 2004Approval Erbitux ImClone - Treatment for Advanced Colorectal Cancer

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