FDA — authorised 21 August 2019
- Application: NDA210828
- Marketing authorisation holder: UIHC PET IMAGING
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 Ga-68-DOTATOC in United States
FDA authorised Ga-68-DOTATOC on 21 August 2019
Marketing authorisations
FDA
- Marketing authorisation holder: UIHC PET IMAGING
- Status: approved
Ga-68-DOTATOC 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-DOTATOC approved in United States?
Yes. FDA authorised it on 21 August 2019; FDA has authorised it.
Who is the marketing authorisation holder for Ga-68-DOTATOC in United States?
UIHC PET IMAGING holds the US marketing authorisation.