Posted by Michael Wonder on 15 Sep 2021
PDUFA goal date extension for Nefecon NDA in the U.S.
14 September 2021 - Calliditas Therapeutics today announced that the U.S. FDA has extended the PDUFA goal date for its new drug application seeking accelerated approval for Nefecon to 15 December 2021.
In March 2021 Calliditas filed for FDA approval using the accelerated approval program, based on the proteinuria outcome as previously discussed with the Agency, reflecting data from the 200 patients in Part A of the NefIgArd trial.
