Prescription medicine
Mitomycin Brand names: Zusduri, Jelmyto, Mitosol, Mutamycin; first approved as Mitozytrex
Mitomycin (Zusduri) is a prescription medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 11 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the mitomycin FDA label on DailyMed (effective April 22, 2025, Accord Healthcare, Inc.); the NDA 50763 record on Drugs@FDA; every mitomycin label on DailyMed.
Highlights of the record
FDA label of April 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Mitomycin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of mitomycin (see WARNINGS and ADVERSE REACTIONS sections). Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure has been reported in patients receiving systemic mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin as a single agent or in combination with other cytotoxic drugs, however, most cases occur at doses ≥60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this syndrome. The incidence of the syndrome has not been defined.
Used for
From the label: indications and usageMitomycin for Injection is not recommended as single-agent, primary therapy.
Forms and strengths
- 20 mg
- 40 mg
- 5 mg/10ml
- 20 mg/40ml
- 40 mg/80ml
Injection (powder) (lyophilized) for solution; kit.
On the market
- Earliest approval on file
- November 14, 2002 Mitozytrex, Supergen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first August 24, 1981; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 11 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- January 20, 2031 Zusduri powder; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2012 1 Class I among all firms' recalls; latest June 12, 2019; 20 more by firms not listed as its makers
- FAERS reports
- 3,418 through July 30, 2026
What is mitomycin used for?
From the label: indications and usageMitomycin for Injection is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.
Conditions named in the indications of mitomycin's FDA labels, with every medicine labeled for each:
From other mitomycin labelsGlaucoma: Mitosol ® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery.
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (Mitomycin), Accord Healthcare, Inc., effective April 22, 2025 (SPL set ff676355-313d-4575-8f2f-e4a1e9527477), via openFDA; the full label on DailyMed
Is there a generic for mitomycin (Zusduri)?
The FDA approved the first generic mitomycin on August 24, 1981. 13 generic applications are approved; 10 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 mitomycin from 11 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 4 patents for Zusduri powder, the last expiring on January 20, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2002 earliest approval on file
- 1981 first generic approved
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has mitomycin been recalled?
The FDA's Enforcement Report lists 22 recalls naming mitomycin since 2012: 1 Class I (the most serious), 21 Class II, 0 Class III; 1 still ongoing. 20 of them are by firms that FDA's NDC Directory does not list as a maker of mitomycin 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 |
|---|---|---|---|
| December 30, 2022 | Class II | Northern VA Compounders PLLC not a listed maker | Lack of Assurance of Sterility |
| December 22, 2022 | Class II | Pharmacy Innovations not a listed maker | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. |
| October 7, 2022 | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder not a listed maker | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products … |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
| January 11, 2018 | Class II | Premier Pharmacy Labs Inc not a listed maker | Labeling: Label Error on Declared Strength |
| September 21, 2016 | Class II | Wells Pharmacy Network LLC not a listed maker | Lack of Assurance of Sterility |
| June 2, 2015 | Class II | The Compounding Pharmacy of America not a listed maker | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility |
| October 6, 2014 | Class II | Oregon Compounding Centers, Inc. dba Creative Compounds not a listed maker | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the mitomycin label say about other medicines?
The mitomycin label names no other medicine on this site. The labels of 1 other medicine name mitomycin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name mitomycin
Source: FDA drug label (Mitomycin), Accord Healthcare, Inc., effective April 22, 2025 (SPL set ff676355-313d-4575-8f2f-e4a1e9527477), via openFDA; the full label on DailyMed
What do FAERS reports show for mitomycin?
The FDA Adverse Event Reporting System holds 3,418 reports that list mitomycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 392 are coded as a death and 983 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 next?
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Mitomycin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other