FDA — authorised 18 January 2002
- Application: NDA021232
- Marketing authorisation holder: SWEDISH ORPHAN
- Status: approved
🇺🇸 Orfadin in United States
FDA authorised Orfadin on 18 January 2002
Marketing authorisations
FDA — authorised 22 April 2016
- Application: NDA206356
- Marketing authorisation holder: SWEDISH ORPHAN
- Local brand name: ORFADIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 26 July 2017
- Application: NDA209449
- Marketing authorisation holder: CYCLE
- Local brand name: NITYR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 2019
- Application: ANDA211041
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: NITISINONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 May 2022
- Application: ANDA212390
- Marketing authorisation holder: MEDUNIK
- Local brand name: NITISINONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 May 2023
- Application: ANDA216201
- Marketing authorisation holder: ETON
- Local brand name: NITISINONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Orfadin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Orfadin approved in United States?
Yes. FDA authorised it on 18 January 2002; FDA authorised it on 22 April 2016; FDA authorised it on 26 July 2017.
Who is the marketing authorisation holder for Orfadin in United States?
SWEDISH ORPHAN holds the US marketing authorisation.