Spectrum Pharmaceuticals, Inc. (SPPI) said it received notification that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application, or sNDA, for FUSILEV for Injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal date for the sNDA is October 8, 2009.
FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
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