Ardelyx, Inc. today announced that it received a letter from the U.S. Food and Drug Administration on July 13, 2021, stating that, as part of its ongoing review of the company’s New Drug Application (“NDA”) for the control of serum phosphorus in adult patients with chronic kidney disease (“CKD”) on dialysis, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
July 19, 2021
· 3 min read