Posted by Michael Wonder on 23 Mar 2018
Progenics Pharmaceuticals announces three month extension of PDUFA date for Azedra (iobenguane I 131)
22 March 2018 - Progenics Pharmaceuticals announced today that the Company has received notification from the U.S. FDA that the Agency will extend its review of the new drug application for Azedra (iobenguane I 131) by three months to 30 July 2018.
The extension is the result of the submission of additional Chemistry, Manufacturing, and Controls information by Progenics, which required additional time for FDA review. The standard three-month extension is not related to the efficacy or safety data of Azedra.
