PDUFA date extension received for Somakit-TATE
Additionally, AAA also announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its Priority Review of the Company’s New Drug Application (NDA) for Somakit-TATE (kit for the Preparation of 68Ga-DOTATATE for Injection), an investigational kit for neuroendocrine tumor diagnosis and follow-up. The PDUFA date has been extended by the standard extension period of three months from 1 March 2016 to the new goal date of 1 June 2016.