Auryxia

Controls serum phosphorus levels. NDA 205874, held by Keryx Biopharms. Ferric Citrate.

As of Nov 13, 2026, NDA 205874 (Auryxia), held by Keryx Biopharms, was first approved by FDA on Sep 5, 2014, with 13 approved supplements and 0 published complete response letters.

First approved: Sep 5, 2014
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ferric citrate tablets are a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. Ferric citrate tablets are an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. 1.1 Hyperphosphatemia in Chronic Kidney Disease on Dialysis

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Nov 6, 2017	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 5, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
AuryxiaEQ 210MG IRON · tablet;oral	Ferric Citrate	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Jan 19, 2024	Supplement 29Labeling · Standard review	Approved	Letter Label
Mar 10, 2021	Supplement 27Labeling · Standard review	Approved	Label Letter
Nov 6, 2017	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 19, 2016	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 9, 2016	Supplement 10Manufacturing · Standard review	Approved	None posted
May 2, 2016	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 27, 2015	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 4, 2015	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 21, 2015	Supplement 4Labeling · Standard review	Approved	Letter Label
Jul 14, 2015	Supplement 5Manufacturing · Standard review	Approved	None posted
May 22, 2015	Supplement 3Manufacturing · Standard review	Approved	None posted
May 18, 2015	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 15, 2014	Supplement 1Labeling · Standard review	Approved	Label Letter
Sep 5, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 205874
Drugs@FDA: Overview at FDA
Company: Keryx Biopharms

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters