Spectrum Pharma Fusilev RTU formulation receives FDA approval

Spectrum Pharma’s Fusilev injection has been approved as the 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 antagonists.

The product is currently under review by the FDA for use in advanced metastatic colorectal cancer.

Spectrum Pharma president, chairman and CEO Rajesh Shrotriya said the RTU formulation provides an additional option for physician and medical staff use.

"The RTU formulation requires no reconstitution, and is of a higher strength than the currently available lyophilized formulation," Shrotriya said.