FDA declines Fusilev NDA for colorectal cancer
Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for FUSILEV(R) in Advanced Metastatic Colorectal Cancer – A Complete Response letter is issued by the U.S. Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for injection for treatment of patients with advanced metastatic colorectal cancer.