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Cardiovascular and Renal Drugs Advisory Committee (CRDAC)

  • IQVIA Solutions Denmark A/S Denmark (map)

The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has scheduled a meeting on Wednesday, November 16, 2022. In the meeting, the committee will discuss new drug application (NDA-213931) for tenapanor hydrochloride tablets, submitted by Ardelyx for the control of serum phosphorus levels in adults with chronic kidney disease on dialysis. The committee will be asked to comment on whether the size of the treatment effect on serum phosphorus is clinically meaningful and whether tenapanor’s benefits outweigh its risks.

Source:: https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-16-2022-meeting-cardiovascular-and-renal-drugs-advisory-committee-meeting-announcement
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