FDA — authorised 17 April 2018
- Application: BLA761068
- Marketing authorisation holder: KYOWA KIRIN
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA authorised Crysvita on 17 April 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 17 April 2018.
KYOWA KIRIN holds the US marketing authorisation.