Ferric Carboxymaltose

For heart failure and New York Heart Association class II/III. Sold as Injectafer. Every FDA application for this active ingredient: 1 branded and 3 generic.

As of Nov 15, 2026, FDA lists 4 applications for Ferric Carboxymaltose (sold as Injectafer), first approved Jul 25, 2013, with 4 new uses approved and 0 published complete response letters.

First approved: Jul 25, 2013
Applications: 4
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $119M
First approved in Japan: Mar 26, 2019

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Injectafer	Part B	$119M	-9%	66,126

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

FDA Adds Boxed Warning to Labeling for Ferric Carboxymaltose Injection (Injectafer) to Describe Risk of Low Phosphate LevelsSep 1, 2026 · boxed warning

Approvals in Japan (PMDA)

First approved in Japan 68 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Ferinject, new ingredientA drug with a new active ingredient indicated for the treatment of iron-deficiency anemia. · Zeria Pharmaceutical Co., Ltd. · Mar 26, 2019

Clinical Trials

24 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Iron Repletion in Cystic FibrosisCystic Fibrosis, Iron Deficiencies · University of Michigan	Phase 4	Not yet recruiting	Oct 29, 2026
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeIRestless Legs Syndrome (RLS) · University Hospital, Montpellier	Phase 2	Not yet recruiting	Sep 16, 2026
Ferric Carboxymaltose Versus Iron Sucrose for Iron Deficiency Anemia After Radical Gastrectomy for Gastric CancerGastric Cancer (GC), Iron Deficiency Anemia (IDA) · Zhaojian Niu,MD	Phase 4	Not yet recruiting	Aug 19, 2026
Comparing Two Intravenous Iron Treatments for Anemia in Kurdish Pregnant WomenIron Deficiency Anemia in Pregnancy · Hawler Medical University	Not applicable	Not yet recruiting	Jul 23, 2026
A Study to Test the Non-Inferiority of Ferric Bepectate IV Against Ferric Carboxymaltose in Patients With Iron Deficiency AnemiaIron Deficiency Anemia (IDA) · AFT Pharmaceuticals, Ltd.	Phase 3	Not yet recruiting	Jul 7, 2026
Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting ConditionsHealthy Adult · Sichuan Huiyu Pharmaceutical Co., Ltd	Phase 1	Recruiting	May 26, 2026
Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary SyndromeAcute Coronary Syndromes (ACS), Iron Deficiencies · Fundación para la Investigación del Hospital Clínico de Valencia	Phase 4	Recruiting	Mar 17, 2026
The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency DepartmentIron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, Iron Deficiency Anaemia Due to Dietary Causes · Children's Hospital of Orange County	Phase 4	Not yet recruiting	Feb 17, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jul 25, 2013	InjectaferNDA 203565 · New formulation or manufacturer	Am Regent	16	Marketed
Jun 25, 2026	Ferric CarboxymaltoseANDA 212572	Mylan Labs Ltd	0	Marketed
Jun 25, 2026	Ferric CarboxymaltoseANDA 217076	Mylan	0	Marketed
Jun 25, 2026	Ferric CarboxymaltoseANDA 217769	Mylan	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA