Quick answers
- What is Mitoxantrone used for?
- The FDA-approved label (Mitoxantrone, Hospira, Inc., July 14, 2025) says: “Mitoxantrone is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone is not indicated in the treatment of patients with primary progressive multiple sclerosis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mitoxantrone have a boxed warning?
- Yes. The FDA label for Mitoxantrone has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Mitoxantrone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mitoxantrone been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started December 3, 2014 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Mitoxantrone?
- 3 companies list prescription products of Mitoxantrone in the FDA NDC Directory, including Meitheal Pharmaceuticals Inc., Hospira, Inc. and Fresenius Kabi USA, LLC.
What Mitoxantrone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Mitoxantrone is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone is not indicated in the treatment of patients with primary progressive multiple sclerosis. …
— FDA label: Mitoxantrone, Hospira, Inc., effective July 14, 2025. Read the full label on DailyMed →
The FDA has 3 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
3 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution, concentrate · Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 4 in the FDA NDC Directory |
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.
- Meitheal Pharmaceuticals Inc.2 products
- Hospira, Inc.1 product
- Fresenius Kabi USA, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA076871Hospira · April 11, 2006
- ANDA077356Meitheal · April 11, 2006
- ANDA077496Fresenius Kabi USA · April 11, 2006
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 3, 2014 · Class I · Terminated · D-0433-2015
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 6 — Hospira Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 197989 |
|---|---|
| SPL set ID of the quoted label | accf9569-4b57-4e83-a7db-4e890a75d1ba |
| FDA labels (SPL) | 3 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | MITOXANTRONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Mitoxantrone, Hospira, Inc., effective July 14, 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 →