MGI PHARMA, INC. (MOGN) Release: Saforis (TM) NDA Accepted By U.S. FDA For Priority Review; PDUFA Is October 12, 2006
6/13/2006 5:17:09 PM
MINNEAPOLIS--(BUSINESS WIRE)--June 12, 2006--MGI PHARMA, INC. (Nasdaq:MOGN), today announced that the New Drug Application (NDA) for Saforis(TM) (glutamine in UpTec(TM)) Powder for Oral Suspension has been accepted for priority review by the U.S. Food and Drug Administration (FDA). A Prescription Drug User Fee Act (PDUFA) goal date of October 12, 2006 has been established for review of the Saforis application. Saforis is an investigational drug for the prevention and treatment of oral mucositis in patients receiving mucotoxic cancer therapy.
comments powered by