Posted by Michael Wonder on 20 Sep 2020
Ardelyx announces FDA acceptance for filing of its new drug application of tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis
15 September 2020 - New drug application supported by data from expansive clinical development program demonstrating tenapanor's use as foundational therapy.
Ardelyx today announced that the U.S. FDA has accepted its new drug application of tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
The FDA has set a Prescription Drug User Fee Act goal date of 29 April 2021.
