FDA — authorised 1 December 2020
- Application: NDA212642
- Marketing authorisation holder: UNIV CA LOS ANGELES
- Local brand name: GALLIUM GA 68 GOZETOTIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 68Ga-PSMA-11 in United States
FDA authorised 68Ga-PSMA-11 on 1 December 2020
Marketing authorisations
FDA — authorised 1 December 2020
- Application: NDA212643
- Marketing authorisation holder: UNIV OF CA SAN FRAN
- Local brand name: GALLIUM GA 68 GOZETOTIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 20 March 2025
- Application: NDA219592
- Marketing authorisation holder: TELIX INNOVATIONS
- Local brand name: GOZELLIX
- Indication: POWDER — INTRAVENOUS
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is 68Ga-PSMA-11 approved in United States?
Yes. FDA authorised it on 1 December 2020; FDA authorised it on 1 December 2020; FDA authorised it on 20 March 2025.
Who is the marketing authorisation holder for 68Ga-PSMA-11 in United States?
UNIV CA LOS ANGELES holds the US marketing authorisation.