Quick answers
- What is Deferoxamine mesylate used for?
- The FDA-approved label (Desferal, Novartis Pharmaceuticals Corporation, June 17, 2025) says: “DESFERAL is an iron-chelating agent indicated: As an adjunct to standard measures for the treatment of acute iron intoxication. For the treatment of transfusional iron overload in patients with chronic anemia. Limitations of Use Desferal is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Deferoxamine mesylate have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Deferoxamine mesylate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Deferoxamine mesylate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Deferoxamine mesylate?
- 6 companies list prescription products of Deferoxamine mesylate in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Apotex Corp. and Gland Pharma Limited.
What Deferoxamine mesylate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DESFERAL is an iron-chelating agent indicated: As an adjunct to standard measures for the treatment of acute iron intoxication. For the treatment of transfusional iron overload in patients with chronic anemia. Limitations of Use Desferal is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder). …
— FDA label: Desferal, Novartis Pharmaceuticals Corporation, effective June 17, 2025. Read the full label on DailyMed →
The FDA has 6 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Injection, powder, for solution |
|---|---|
| Route | Intravenous · Intramuscular · Subcutaneous |
| Prescription products | 9 in the FDA NDC Directory |
| Brand names | Desferal |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Fresenius Kabi USA, LLC2 products
- Apotex Corp.2 products
- Gland Pharma Limited2 products
- Novartis Pharmaceuticals Corporation1 product
- Mitem Pharma1 product
- Hospira, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA016267 DESFERAL | Mitem Pharma | April 1, 1968 | 40, latest September 9, 2022 2022: Labeling · 2016: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
Generic approvals (3)
- ANDA076019Hospira · March 17, 2004
- ANDA078718Fresenius Kabi USA · September 15, 2009
- ANDA207384Gland · September 29, 2017
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1731345, 1731350, 1731352 |
|---|---|
| SPL set ID of the quoted label | a7174843-5965-49fc-b842-f7eff7b48bbc |
| FDA labels (SPL) | 6 |
| FDA applications | NDA016267, 3 ANDA |
| Active ingredients (FDA) | DEFEROXAMINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Desferal, Novartis Pharmaceuticals Corporation, effective June 17, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →