Orexo announces that Zubsolv™ has been accepted for review by the U.S. Food and Drug Administration (FDA)
FDA has informed Orexo that the Zubsolv New Drug Application (NDA) has been accepted for review, and that the Prescription Drug User Fee Act (PDUFA) action date will be July 6, 2013.Orexo submitted the application for approval of Zubsolv on September 6, 2012. Following a preliminary assessment of completeness, the application is now entering the substantive review stage. Orexo expects Zubsolv to be approved 10 months after submission to the FDA, in July 2013. The launch of Zubsolv is planned for September 2013. “Today’s notice from the FDA is yet another step for Orexo towards becoming a