FDA accepts sNDA for colorectal cancer indication for Fusilev

Spectrum Pharmaceuticals announced that it received notification that the 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. Fusilev is the pharmacologically active isomer of leucovorin and is available as a freeze-dried powder for IV injection after reconstitution.  

Fusilev is already indicated for use in osteosarcoma, to reduce toxicity of high-dose methotrexate (MTX) therapy and to reduce toxicity and counteract effects of impaired MTX elimination and of inadvertent overdose of folic acid antagonists.

For more information call (877) 387-4538 or visit www.fusilev.com.