Search Orphan Drug Designations and Approvals
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Generic Name: | cetuximab | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | cetuximab |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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