FDA — authorised 15 April 2020
- Application: NDA211728
- Marketing authorisation holder: UROGEN PHARMA
- Local brand name: JELMYTO
- Indication: POWDER — PYELOCALYCEAL
- Status: approved
🇺🇸 Mitomycin for pyelocalyceal solution in United States
FDA authorised Mitomycin for pyelocalyceal solution on 15 April 2020
Marketing authorisation
Frequently asked questions
Is Mitomycin for pyelocalyceal solution approved in United States?
Yes. FDA authorised it on 15 April 2020.
Who is the marketing authorisation holder for Mitomycin for pyelocalyceal solution in United States?
UROGEN PHARMA holds the US marketing authorisation.