FDA — authorised 24 August 1981
- Status: approved
🇺🇸 Mitozytrex in United States
FDA authorised Mitozytrex on 24 August 1981
Marketing authorisations
FDA — authorised 30 April 1998
- Application: ANDA064144
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 December 1999
- Application: ANDA064180
- Marketing authorisation holder: HIKMA
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 November 2002
- Application: NDA050763
- Marketing authorisation holder: SUPERGEN
- Local brand name: MITOZYTREX
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 February 2012
- Application: NDA022572
- Marketing authorisation holder: GLAUKOS
- Local brand name: MITOSOL
- Indication: FOR SOLUTION — TOPICAL
- Status: approved
FDA — authorised 13 October 2017
- Application: ANDA202670
- Marketing authorisation holder: RK PHARMA
- Status: approved
FDA — authorised 13 October 2017
- Application: ANDA203386
- Marketing authorisation holder: RK PHARMA
- Status: approved
FDA — authorised 20 October 2021
- Application: ANDA215687
- Marketing authorisation holder: GLAND
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 September 2022
- Application: ANDA214504
- Marketing authorisation holder: MEITHEAL
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 September 2022
- Application: ANDA214505
- Marketing authorisation holder: MEITHEAL
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 November 2022
- Application: ANDA216648
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 12 June 2025
- Application: NDA215793
- Marketing authorisation holder: UROGEN PHARMA
- Indication: Type 3 - New Dosage Form
- Status: approved
The FDA approved Mitozytrex, a new dosage form, on 12 June 2025. The marketing authorisation holder is UROGEN PHARMA. This approval was granted under the standard expedited pathway. Mitozytrex is indicated for a specific use, as classified under Type 3 of the FDA's approval categories.
Mitozytrex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Mitozytrex approved in United States?
Yes. FDA authorised it on 24 August 1981; FDA authorised it on 30 April 1998; FDA authorised it on 23 December 1999.
Who is the marketing authorisation holder for Mitozytrex in United States?
Kyowa Kirin Co., Ltd. is the originator. The local marketing authorisation holder may differ — check the official source linked above.