FDA Grants Appeal for Ardelyx’s XPHOZAH® (tenapanor)
- Thursday, December 29, 2022, 7:13
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Office of New Drugs directs the Division of Cardiology and Nephrology to work with Ardelyx to develop a label to support the commercialization of XPHOZAH; Ardelyx to resubmit NDA in the first half of 2023 Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor,…