FDA — authorised 21 August 2019
- Marketing authorisation holder: UIHC PET IMAGING
- Status: approved
🇺🇸 Ga 68 Dotatate in United States
FDA authorised Ga 68 Dotatate on 21 August 2019
Marketing authorisation
Ga 68 Dotatate 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 Ga 68 Dotatate approved in United States?
Yes. FDA authorised it on 21 August 2019.
Who is the marketing authorisation holder for Ga 68 Dotatate in United States?
UIHC PET IMAGING holds the US marketing authorisation.