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In this section: Postmarket Drug Safety Information for Patients and Providers

Information on Cetuximab (marketed as Erbitux)

FDA approves Erbitux (cetuximab) to treat patients with advanced colorectal cancer that has spread to other parts of the body. Erbitux is the first monoclonal antibody approved to treat this type of cancer and is indicated as a combination treatment to be given intravenously with irinotecan, another drug approved to fight colorectal cancer, or alone if patients cannot tolerate irinotecan.

Labeling and Regulatory History from Drug@FDA

Approval Letter for Cetuximab 02.12.2004
Label for Cetuximab 02.14.2004
Prescribing and Labeling Information for Cetuximab (marketed as Erbitux)

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