FDA — authorised 24 August 1981
- Application: ANDA062336
- Marketing authorisation holder: BRISTOL MYERS
- Local brand name: MUTAMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Mitomycin C in United States
FDA authorised Mitomycin C on 24 August 1981 · 511 US adverse-event reports
Marketing authorisations
FDA
- Application: NDA050450
- Marketing authorisation holder: BRISTOL
- Local brand name: MUTAMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 511
Most-reported reactions
- Diarrhoea — 76 reports (14.87%)
- Off Label Use — 62 reports (12.13%)
- Neutropenia — 58 reports (11.35%)
- Nausea — 57 reports (11.15%)
- Thrombocytopenia — 54 reports (10.57%)
- Drug Ineffective — 52 reports (10.18%)
- Disease Progression — 44 reports (8.61%)
- Vomiting — 39 reports (7.63%)
- Fatigue — 36 reports (7.05%)
- Pyrexia — 33 reports (6.46%)
Other Oncology approved in United States
Frequently asked questions
Is Mitomycin C approved in United States?
Yes. FDA authorised it on 24 August 1981; FDA has authorised it.
Who is the marketing authorisation holder for Mitomycin C in United States?
BRISTOL MYERS holds the US marketing authorisation.