Posted by Michael Wonder on 09 Jan 2019
RadioMedix and Curium announce FDA fast track designation for 64Cu dotatate
9 January 2019 - RadioMedix and its commercial partner Curium announced today that their investigational diagnostic radiopharmaceutical, 64Cu dotatate, was granted Fast Track designation by the U.S. FDA.
64Cu dotatate is a PET diagnostic agent being studied for somatostatin receptor expressing neuroendocrine tumours. RadioMedix has completed the Phase III clinical trial of the agent and expects to file a New Drug Application with the FDA in 2019.
64Cu dotatate is anticipated to be the first neuroendocrine PET diagnostic available to ALL medical centers with PET capability across the country.
