Prescription medicine
Mitoxantrone First approved as Novantrone
Mitoxantrone (Novantrone) is a prescription medicine with an FDA approval on record since 1987. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the mitoxantrone FDA label on DailyMed (effective April 24, 2025, Meitheal Pharmaceuticals Inc.); the NDA 19297 record on Drugs@FDA; every mitoxantrone label on DailyMed.
Highlights of the record
FDA label of April 24, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Mitoxantrone injection (concentrate) should be administered under the supervision of a physician experienced in the use of cytotoxic chemotherapy agents. Mitoxantrone injection (concentrate) should be given slowly into a freely flowing intravenous infusion. It must never be given subcutaneously, intramuscularly, or intra-arterially. Severe local tissue damage may occur if there is extravasation during administration (see ADVERSE REACTIONS, General, Cutaneous and DOSAGE AND ADMINISTRATION, Preparation and Administration Precautions ). NOT FOR INTRATHECAL USE. Severe injury with permanent sequelae can result from intrathecal administration (see WARNINGS, General ). Except for the treatment of acute nonlymphocytic leukemia, mitoxantrone injection (concentrate) therapy generally should not be given to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 . In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving mitoxantrone injection (concentrate). Cardiotoxicity Congestive heart failure (CHF), potentially fatal, may occur either during therapy with mitoxantrone injection (concentrate) or months to years after termination of therapy. […]
Used for
From the label: indications and usageMitoxantrone injection, USP (concentrate) 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).
Forms and strengths
- 2 mg/ml
Injection (solution) (concentrate); injection (solution).
On the market
- Earliest approval on file
- December 23, 1987 Novantrone, Emd Serono; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first April 11, 2006; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2014 1 Class I among all firms' recalls; latest December 3, 2014; 2 more by firms not listed as its makers
- FAERS reports
- 6,237 through July 30, 2026
What is mitoxantrone used for?
From the label: indications and usageMitoxantrone injection, USP (concentrate) 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 injection, USP (concentrate) is not indicated in the treatment of patients with primary progressive multiple sclerosis. […]
Conditions named in the indications of mitoxantrone's FDA labels, with every medicine labeled for each:
From other mitoxantrone labelsLeukemia, lymphoma and myeloma: Mitoxantrone injection, USP (concentrate) in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults.
FDA pharmacologic class: Topoisomerase Inhibitor.
Source: FDA drug label (mitoXANTRONE), Meitheal Pharmaceuticals Inc., effective April 24, 2025 (SPL set 1634528a-30c5-4309-acc8-4c0293ae14ae), via openFDA; the full label on DailyMed
What does the patient leaflet for mitoxantrone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about mitoXANTRONE?mitoXANTRONE can cause serious side effects, including: decrease in the ability of your bone marrow to make blood cells (myelosuppression). Your doctor may do blood tests during treatment with mitoXANTRONE to check your blood cell counts. The symptoms of myelosuppression can include: feeling tired increased infections bruising and bleeding easily heart problems (congestive heart failure) that may lead to death even in people who have never had heart problems before. Heart failure can happen while you receive mitoXANTRONE, or months to years after you stop receiving mitoXANTRONE. Your risk of heart failure increases the more mitoXANTRONE you receive. Call your doctor or get medical help right away if you have any of these problems during or after treatment with mitoXANTRONE: shortness of breath swelling of your ankles or feet sudden weight gain fast heartbeat or pounding in your chest Before receiving mitoXANTRONE for the first time, you should have the following tests done: physical examination a test to check your heart’s electrical activity (electrocardiogram) a test to check your heart’s ability to pump blood If you receive mitoXANTRONE to treat Multiple Sclerosis (MS), your doctor should also do the tests above: before you receive each mitoXANTRONE dose yearly after you stop receiving mitoXANTRONE treatment acute myeloid leukemia (AML). Receiving mitoXANTRONE increases your risk of AML. AML is a cancer of the blood-forming cells of your bone marrow. Symptoms of AML can include: feeling unusually tired and weak increased infections bruising and bleeding easily fever pain in your bones trouble breathing unexplained weight loss night sweats skin problems at your injection site. […]
Source: FDA drug label (mitoXANTRONE), Meitheal Pharmaceuticals Inc., effective April 24, 2025 (SPL set 1634528a-30c5-4309-acc8-4c0293ae14ae), via openFDA; the full label on DailyMed
Is there a generic for mitoxantrone (Novantrone)?
The FDA approved the first generic mitoxantrone on April 11, 2006. 7 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists mitoxantrone from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1987 earliest approval on file
- 2006 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has mitoxantrone been recalled?
The FDA's Enforcement Report lists 3 recalls naming mitoxantrone since 2014: 1 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of mitoxantrone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 13, 2016 | Class III | Teva Pharmaceuticals USA not a listed maker | Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life. |
| May 31, 2016 | Class III | Teva North America not a listed maker | Failed Impurities/Degradation Specifications: High out of specification results for Impurity D. |
| December 3, 2014 | Class I | Hospira Inc. | Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the mitoxantrone label say about other medicines?
The mitoxantrone label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name mitoxantrone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cytarabine | warnings | In first-line comparative trials of mitoxantrone injection + cytarabine vs. daunorubicin + cytarabine in adult patients with previously untreated ANLL, therapy was associated with congestive heart failure in 6.5% of patients on each arm. |
| Daunorubicin | warnings | Cardiac Effects Because of the possible danger of cardiac effects in patients previously treated with daunorubicin or doxorubicin, the benefit-to-risk ratio of mitoxantrone injection therapy in such patients should be determined before starting therapy. |
| Doxorubicin | warnings | Cardiac Effects Because of the possible danger of cardiac effects in patients previously treated with daunorubicin or doxorubicin, the benefit-to-risk ratio of mitoxantrone injection therapy in such patients should be determined before starting therapy. |
| Prednisone | warnings | In a randomized comparative trial of mitoxantrone injection plus low-dose prednisone vs. low-dose prednisone, 7 of 128 patients (5.5 %) treated with mitoxantrone injection had a cardiac event defined as any decrease in LVEF below the normal range, congestive heart failure (n = 3), or myocardial ischemia. |
Other labels that name mitoxantrone
Source: FDA drug label (mitoXANTRONE), Meitheal Pharmaceuticals Inc., effective April 24, 2025 (SPL set 1634528a-30c5-4309-acc8-4c0293ae14ae), via openFDA; the full label on DailyMed
What do FAERS reports show for mitoxantrone?
The FDA Adverse Event Reporting System holds 6,237 reports that list mitoxantrone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,662 are coded as a death and 2,215 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as mitoxantrone?
36 other medicines are given the same way (intravenous) and in the same FDA class as mitoxantrone or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other topoisomerase inhibitors
- the pharmacologic class, with prices and generics
- Mitoxantrone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other