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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: cetuximab
Trade Name: Erbitux
Date Designated: 07/03/2000
Orphan Designation: Treatment of squamous cell cancer of the head and neck in patients who express epidermal growth factor receptor
Orphan Designation Status: Designated/Approved
ImClone Systems Incorporated
33 ImClone Drive
Branchburg, New Jersey 08876
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: cetuximab
Trade Name: Erbitux
Marketing Approval Date: 03/01/2006
Approved Labeled Indication: For use in combination with radiation therapy, for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and for use as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed
Exclusivity End Date: 03/01/2013 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.