Ferric Maltol

Sold as Accrufer. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Ferric Maltol (sold as Accrufer), first approved Jul 25, 2019, with 1 new use approved and 0 published complete response letters.

First approved: Jul 25, 2019
Applications: 1
New uses approved: 1
Complete response letters: 0
First approved in the EU: Feb 18, 2016

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

ACCRUFER 30 MG CAPSULE: $10.09 per unitBrand · +6% in a year

Approvals in the EU (EMA)

First approved in the EU 41 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Feraccru, new substanceNorgine B.V. · Feb 18, 2016

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient WomenAnemia, Iron Deficiency Anemia (IDA) · Pharmanutra S.p.a.	Phase 4	Recruiting	Dec 30, 2025

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Jul 25, 2019	AccruferNDA 212320 · New molecular entity	Shield Tx	5	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