Fusilev Approval History

• FDA approved: Yes (First approved March 7th, 2008)
• Brand name: Fusilev
• Generic name: levoleucovorin
• Company: Spectrum Pharmaceuticals, Inc.
• Treatment for: Folic Acid Antagonist Overdose, Methotrexate Rescue, Colorectal Cancer

Fusilev (levoleucovorin calcium) is a folate analog indicated for rescue after high-dose methotrexate therapy in osteosarcoma, diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists, and for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.

FDA Approval History for Fusilev

Date	Article
May  2, 2011	FDA Approves Fusilev for Use in Patients with Colorectal Cancer
Mar 10, 2008	FDA Approves New Drug Application for Levoleucovorin, Spectrum's First Proprietary Oncology Drug
Sep 13, 2007	FDA Accepts ISO-Vorin New Drug Application Amendment Submitted by Spectrum Pharmaceuticals
Jul  2, 2007	Spectrum Pharmaceuticals Completes the NDA Filing for Isovorin

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Fusilev (levoleucovorin) Consumer Information

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