Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals Announces That FDA Has Accepted FUSILEV™ sNDA for Colorectal Cancer Indication

Published in Cancer Weekly, April 7th, 2009

Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI) announced that it received notification that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental New Drug Application (sNDA) for FUSILEV™ (levoleucovorin) for Injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal (PDUFA) date for the sNDA is October 8, 2009.

The FDA approved FUSILEV on March 7, 2008 for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid...

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Source: Cancer Weekly (2009-04-07)

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