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Fusilev FDA Approval History

FDA Approved: Yes (First approved March 7, 2008)
Brand name: Fusilev
Generic name: levoleucovorin
Dosage form: for Injection
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Methotrexate Rescue, Folic Acid Antagonist Overdose, 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.

Development timeline for Fusilev

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

Further information

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