FDA — authorised 18 January 2002
- Application: NDA021232
- Marketing authorisation holder: SWEDISH ORPHAN
- Local brand name: ORFADIN
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Nitisinone in Arm A in United States
FDA authorised Nitisinone in Arm A 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
Nitisinone in Arm A 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 Nitisinone in Arm A approved in United States?
Yes. FDA authorised it on 18 January 2002; FDA authorised it on 22 April 2016.
Who is the marketing authorisation holder for Nitisinone in Arm A in United States?
SWEDISH ORPHAN holds the US marketing authorisation.