Posted by Michael Wonder on 18 Dec 2022
Ardelyx provides update on FDA appeal for Xphozah (tenapanor) for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis
16 December 2022 - Ardelyx provided an update regarding the appeal to the complete response letter for the new drug application for Xphozah (tenapanor).
Earlier today, Peter Stein, M.D., Director of the Office of New Drugs, Center for Drug Evaluation and Research of the US FDA, requested a meeting with Ardelyx to discuss the status of his review of the appeal.
