FDA — authorised 17 April 2018
- Application: BLA761068
- Marketing authorisation holder: KYOWA KIRIN
- Local brand name: CRYSVITA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 KRN23 in United States
FDA authorised KRN23 on 17 April 2018
Marketing authorisation
KRN23 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is KRN23 approved in United States?
Yes. FDA authorised it on 17 April 2018.
Who is the marketing authorisation holder for KRN23 in United States?
KYOWA KIRIN holds the US marketing authorisation.