FDA — authorised 1 December 2020
- Application: NDA212643
- Marketing authorisation holder: UNIV OF CA SAN FRAN
- Status: supplemented
🇺🇸 Ga-68-PSMA-11 in United States
FDA authorised Ga-68-PSMA-11 on 1 December 2020
Marketing authorisations
FDA — authorised 1 December 2020
- Application: NDA212642
- Marketing authorisation holder: UNIV CA LOS ANGELES
- Status: approved
FDA
- Status: approved
Ga-68-PSMA-11 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Ga-68-PSMA-11 approved in United States?
Yes. FDA authorised it on 1 December 2020; FDA authorised it on 1 December 2020; FDA has authorised it.
Who is the marketing authorisation holder for Ga-68-PSMA-11 in United States?
UNIV OF CA SAN FRAN holds the US marketing authorisation.