Quick answers
- What is Mitomycin used for?
- The FDA-approved label (Mutamycin, Accord BioPharma Inc., March 12, 2025) says: “MUTAMYCIN ® (Mitomycin) 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mitomycin have a boxed warning?
- Yes. The FDA label for Mutamycin has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Mitomycin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mitomycin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Mitomycin?
- 11 companies list prescription products of Mitomycin in the FDA NDC Directory, including Archis Pharma LLC, Hikma Pharmaceuticals USA Inc. and Meitheal Pharmaceuticals Inc..
What Mitomycin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MUTAMYCIN ® (Mitomycin) 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.
— FDA label: Mutamycin, Accord BioPharma Inc., effective March 12, 2025. Read the full label on DailyMed →
The FDA has 18 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.
This label has a boxed warning. Read it on the full label →
18 of 18 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 32 in the FDA NDC Directory |
| Brand names | Mutamycin |
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.
- Archis Pharma LLC4 products
- Hikma Pharmaceuticals USA Inc.4 products
- Meitheal Pharmaceuticals Inc.3 products
- BluePoint Laboratories3 products
- Accord Healthcare Inc.3 products
- Eugia US LLC3 products
- Fresenius Kabi USA, LLC3 products
- Gland Pharma Limited3 products
- Sagent Pharmaceuticals3 products
- Bryant Ranch Prepack2 products
- Accord BioPharma Inc.2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (9)
- ANDA064117Hikma · April 19, 1995
- ANDA064144Accord Hlthcare · April 30, 1998
- ANDA202670Adaptis · October 13, 2017
- ANDA203386Adaptis · October 13, 2017
- ANDA215687Gland · October 20, 2021
- ANDA214504Meitheal · September 6, 2022
- ANDA214505Meitheal · September 8, 2022
- ANDA216648Gland · November 22, 2022
- ANDA216732Eugia Pharma · October 30, 2023
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Mutamycin, Accord BioPharma Inc., effective March 12, 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 →