Feraheme

Treats iron deficiency anemia (IDA). NDA 22180, held by Azurity. Ferumoxytol.

As of Nov 13, 2026, NDA 22180 (Feraheme), held by Azurity, was first approved by FDA on Jun 30, 2009, with 17 approved supplements and 0 published complete response letters.

First approved: Jun 30, 2009
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

who have intolerance to oral iron or have had unsatisfactory response to oral iron
who have chronic kidney disease (CKD).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Feb 2, 2018	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 30, 2009	Original applicationNew active ingredient · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
FerahemeEQ 510MG IRON/17ML (EQ 30MG IRON/ML) · solution;intravenous	Ferumoxytol	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


May 27, 2026	Supplement 26Labeling · Standard review	Approved	Label Letter
Jun 16, 2022	Supplement 25Labeling · Standard review	Approved	Label Letter
Sep 11, 2020	Supplement 24Labeling · Standard review	Approved	Label Letter
Oct 11, 2019	Supplement 23Labeling · Standard review	Approved	Label Letter
Feb 2, 2018	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 22, 2017	Supplement 16Labeling · Standard review	Approved	Letter Label
Nov 15, 2016	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 28, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 26, 2015	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 27, 2015	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 16, 2015	Supplement 13Labeling · Standard review	Approved	Label Letter
Mar 16, 2015	Supplement 11Labeling · Standard review	Approved	Label Letter
Dec 23, 2013	Supplement 10Manufacturing · Standard review	Approved	Label
Jun 5, 2012	Supplement 7Labeling	Approved	None posted
Jun 21, 2011	Supplement 6Labeling	Approved	Label Letter
Nov 24, 2010	Supplement 5Labeling	Approved	Label Letter
Nov 24, 2010	Supplement 3Labeling	Approved	Label Letter
Jun 30, 2009	Original applicationNew active ingredient · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22180
Drugs@FDA: Overview at FDA
Company: Azurity Pharmaceuticals

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