Deferoxamine Mesylate

Treats acute iron intoxication. Sold as Desferal. Every FDA application for this active ingredient: 1 branded and 5 generic.

As of Nov 15, 2026, FDA lists 6 applications for Deferoxamine Mesylate (sold as Desferal), first approved Apr 1, 1968, with 1 new use approved and 0 published complete response letters.

First approved: Apr 1, 1968
Applications: 6
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $555K

Medicare Spending

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


Deferoxamine Mesylate	Part B	$356K	+8%	167
Deferoxamine Mesylate	Part D	$150K	+39%	71
Desferal Mesylate	Part D	$48K	+101%	0

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of sickle cell leg ulcersTheris Medical · designated Mar 15, 2019

Clinical Trials

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


Synergistic Minimally Invasive Surgery and Deferoxamine in ICHIntracerebral Hemorrhage, ICH - Intracerebral Hemorrhage · University of Illinois Chicago	Phase 2 / Phase 3	Not yet recruiting	Sep 9, 2025
The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBALIntracerebral Hemorrhage, Spontaneous Intracerebral Hemorrhage · The George Institute	Phase 3	Recruiting	Jan 8, 2025
ACT-GLOBAL Adaptive Platform Trial for StrokeStroke · The George Institute	Phase 3	Recruiting	Apr 8, 2024

Applications

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


Apr 1, 1968	DesferalNDA 16267 · New molecular entity	Mitem Pharma	40	Marketed
Mar 17, 2004	Deferoxamine MesylateANDA 76019	Hospira	7	Marketed
Mar 31, 2006	Deferoxamine MesylateANDA 76806	Dr Reddys	0	Discontinued
May 30, 2007	Deferoxamine MesylateANDA 78086	Hikma	2	Discontinued
Sep 15, 2009	Deferoxamine MesylateANDA 78718	Fresenius Kabi USA	4	Marketed
Sep 29, 2017	Deferoxamine MesylateANDA 207384	Gland	1	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