Advanced Accelerator Applications Announces New Prescription Drug User Fee Act (PDUFA) date of January 26, 2018, for Lutetium Lu 177 Dotatate (Lutathera®)

AAA today announced that the US Food and Drug Administration (FDA) has acknowledged receipt and considered complete the resubmission of the New Drug Application (NDA) for investigational drug lutetium Lu 177 dotatate* (Lutathera®). The Agency provided a new Prescription Drug User Fee Act (PDUFA) date of January 26, 2018.