Posted by Michael Wonder on 10 Mar 2017
Keryx Biopharmaceuticals announces U.S. FDA filing acceptance of supplemental new drug application for Auryxia (ferric citrate) tablets
8 March 2017 - Keryx Biopharmaceuticals today announced that the U.S. FDA has accepted for review the supplemental new drug application for Auryxia (ferric citrate) tablets.
The application acceptance by the FDA indicates that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act target action date for completion of the FDA’s review is 6 November 2017.
Auryxia is currently approved for use in the U.S. for the control of serum phosphorus levels in patients with end-stage renal disease requiring dialysis. Keryx, with this sNDA submission, is seeking to expand the indication for Auryxia to include the treatment of iron deficiency anemia (IDA) in patients with non-dialysis dependent chronic kidney disease.
