Ardelyx resubmits new drug application to US FDA for Xphozah (tenapanor)

Ardelyx

18 April 2023 - Company expects to receive goal review date in mid May.

Ardelyx today announced the resubmission of a new drug application to the US FDA for the approval of Xphozah (tenapanor) for the control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy.

Read Ardelyx press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier