FDA — authorised 22 January 2021
- Application: NDA213716
- Marketing authorisation holder: AURINIA
- Local brand name: LUPKYNIS
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 LUPKYNIS in United States
FDA authorised LUPKYNIS on 22 January 2021
Marketing authorisation
LUPKYNIS 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 LUPKYNIS approved in United States?
Yes. FDA authorised it on 22 January 2021.
Who is the marketing authorisation holder for LUPKYNIS in United States?
AURINIA holds the US marketing authorisation.