FDA — authorised 8 August 2018
- Application: BLA761051
- Marketing authorisation holder: KYOWA KIRIN
- Local brand name: POTELIGEO
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Mogamulizumab-Kpkc on 8 August 2018
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 8 August 2018.
KYOWA KIRIN holds the US marketing authorisation.