FDA — authorised 1 December 2020
- Application: NDA212643
- Marketing authorisation holder: UNIV OF CA SAN FRAN
- Status: supplemented
🇺🇸 [Ga-68]PSMA in United States
FDA authorised [Ga-68]PSMA on 1 December 2020
Marketing authorisations
FDA — authorised 1 December 2020
- Application: NDA212642
- Marketing authorisation holder: UNIV CA LOS ANGELES
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is [Ga-68]PSMA approved in United States?
Yes. FDA authorised it on 1 December 2020; FDA authorised it on 1 December 2020.
Who is the marketing authorisation holder for [Ga-68]PSMA in United States?
UNIV OF CA SAN FRAN holds the US marketing authorisation.