Active substance
Mitomycin
- US FDA 19
- Health Canada 3
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MITOMYCIN | 20MG/VIAL; 40MG/VIAL | injectable · injection | HIKMA PHARMS | Prescription | 19 Apr 1995 |
| MITOMYCIN | 5MG/VIAL; 20MG/VIAL; 40MG/VIAL | injectable · injection | ACCORD HLTHCARE | Prescription | 30 Apr 1998 |
| MITOMYCIN | 5MG/VIAL; 20MG/VIAL | injectable · injection | HIKMA PHARMS | Prescription | 23 Dec 1999 |
| MITOSOL | 0.2MG/VIAL | for solution · topical | GLAUKOS | Prescription | 7 Feb 2012 |
| MITOMYCIN | 5MG/VIAL; 20MG/VIAL | injectable · injection | RK PHARMA | Prescription | 13 Oct 2017 |
| MITOMYCIN | 40MG/VIAL | injectable · injection | RK PHARMA | Prescription | 13 Oct 2017 |
| JELMYTO | 40MG/VIAL | powder · pyelocalyceal | UROGEN PHARMA | Prescription | 15 Apr 2020 |
| MITOMYCIN | 5MG/VIAL; 20MG/VIAL | injectable · injection | GLAND | Prescription | 20 Oct 2021 |
| MITOMYCIN | 40MG/VIAL | injectable · injection | MEITHEAL | Prescription | 6 Sep 2022 |
| MITOMYCIN | 5MG/VIAL; 20MG/VIAL | injectable · injection | MEITHEAL | Prescription | 8 Sep 2022 |
| MITOMYCIN | 40MG/VIAL | injectable · injection | GLAND | Prescription | 22 Nov 2022 |
| MITOMYCIN | 5MG/VIAL; 20MG/VIAL; 40MG/VIAL | injectable · injection | FRESENIUS KABI USA | Prescription | 5 Apr 2024 |
| ZUSDURI | 40MG/VIAL | powder · intravesical | UROGEN PHARMA | Prescription | 12 Jun 2025 |
| MUTAMYCIN | 5MG/VIAL; 20MG/VIAL; 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | BRISTOL MYERS | Discontinued | 24 Aug 1981 |
| MITOMYCIN | 5MG/VIAL | injectable · injection | HIKMA PHARMS | Discontinued | 19 Apr 1995 |
| MITOMYCIN | 20MG/VIAL | injectable · injection | HOSPIRA | Discontinued | 29 Nov 1995 |
| MITOZYTREX | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | SUPERGEN | Discontinued | 14 Nov 2002 |
| MITOMYCIN | 5MG/VIAL; 20MG/VIAL; 40MG/VIAL | injectable · injection | EUGIA PHARMA | Discontinued | 30 Oct 2023 |
| MUTAMYCIN | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | BRISTOL | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| MITOMYCIN FOR INJECTION | 02230451 | 20 MG / VIAL | POWDER FOR SOLUTION · INTRAVESICAL; INTRAVENOUS | TEVA CANADA LIMITED |
| MITOMYCIN FOR INJECTION USP | 02464691 | 20 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS; INTRAVESICAL | ACCORD HEALTHCARE INC |
| MITOMYCIN FOR INJECTION, USP | 02531941 | 20 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS; INTRAVESICAL | HIKMA CANADA LIMITED |
Safety signals and safety-related labeling changes
- US FDA 4 Oct 2024 JELMYTO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 23 Apr 2021 MITOSOL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.