FDA has accepted and considered complete the resubmission of the NDA for Lutathera.
Advanced Accelerator Applications S.A. (AAA) announced in AUG17 that the Food and Drug Administration (FDA), in the United States, has accepted and considered complete the resubmission of the New Drug Application (NDA) for its investigational drug lutetium Lu 177 dotatate (Lutathera). Lutathera is the brand name for the radiologic used in Peptide Receptor Radionuclide Therapy (PRRT). The FDA has set an action date of Jan 26, 2018. Read more >>> https://goo.gl/sjURwh (2/2)