Eloxatin Information 

On January 9, 2004, the Food and Drug Administration announced the approval of Eloxatin (oxaliplatin) injection for the initial treatment of advanced colorectal cancer. Eloxatin is a platinum-based anticancer drug, given in combination with infusional 5-fluorouracil plus leucovorin (5FU/LV). The data showed that, compared to the standard treatment (irinotecan plus 5FU/LCV), the oxaliplatin 5FU/LV regimen was superior in survival, in shrinking tumors, and in delaying tumor regrowth. Eloxatin was previously approved (August 9, 2002) to treat patients with colorectal cancer whose disease has become worse following initial therapy.

• Labeling and regulatory history from Drugs@FDA
• Approval Letter (1/9/2004)
• FDA Press Release (8/9/2002)
• Questions and Answers about Eloxatin

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FDA/Center for Drug Evaluation and Research
Last Updated: January 16, 2007
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