Ardelyx (ARDX) says FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments for Tenapanor at this time

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Go back to Ardelyx (ARDX) says FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments for Tenapanor at this time

Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis

July 19, 2021 4:01 PM EDT

FREMONT, Calif. and WALTHAM, Mass., July 19, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that it received a letter from the U.S. Food and Drug Administration (the "FDA") 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... More