SAFORIS NDA ACCEPTED BY FDA
MGI Pharma has announced that the new drug application (NDA) for Saforis (glutamine in UpTec) Powder for Oral Suspension has been accepted for priority review by the FDA.
One pivotal Phase III trial and several supportive studies form the foundation of the NDA. The Phase III trial of Saforis was successfully completed in 326 patients with breast cancer who were receiving anthracycline-based chemotherapy regimens. The primary endpoint of this trial, defined as a reduction in incidence and severity of oral mucositis, was met.