🇺🇸 64Cu-DOTATATE in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised 64Cu-DOTATATE on 3 September 2020

Marketing authorisation

FDA — authorised 3 September 2020

Application: NDA213227
Marketing authorisation holder: CURIUM
Local brand name: DETECTNET
Indication: SOLUTION — INTRAVENOUS
Status: approved

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Frequently asked questions

Is 64Cu-DOTATATE approved in United States?

Yes. FDA authorised it on 3 September 2020.

Who is the marketing authorisation holder for 64Cu-DOTATATE in United States?

CURIUM holds the US marketing authorisation.