FDA — authorised 8 August 2018
- Application: BLA761051
- Marketing authorisation holder: KYOWA KIRIN
- Status: supplemented
🇺🇸 Poteligeo in United States
FDA authorised Poteligeo on 8 August 2018
Marketing authorisations
FDA
- Status: approved
Poteligeo 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 Poteligeo approved in United States?
Yes. FDA authorised it on 8 August 2018; FDA has authorised it.
Who is the marketing authorisation holder for Poteligeo in United States?
KYOWA KIRIN holds the US marketing authorisation.