Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Spectrum Pharmaceuticals has filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) for ready-to-use formulation of Fusilev (levoleucovorin) for injection as a treatment for colorectal cancer.
Subscribe to our email newsletter
Fusilev, a novel folate analog, is available in vials as freeze-dried powder.
Fusilev is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
Spectrum Pharma chairman of the board of directors, president and CEO Rajesh Shrotriya said that if approved, they believe a RTU formulation of Fusilev, as the name implies will be more convenient for the staff and easy to use.
"RTU formulation requires no reconstitution, and since it will also be of a higher strength than the currently available lyophilized formulation, the healthcare provider’s time to administer Fusilev to colorectal cancer patients will be considerably reduced," Shrotriya said.