FDA — authorised 5 September 2014
- Marketing authorisation holder: KERYX BIOPHARMS
- Status: approved
🇺🇸 Auryxia in United States
FDA authorised Auryxia on 5 September 2014
Marketing authorisations
FDA — authorised 5 September 2014
- Application: NDA205874
- Marketing authorisation holder: KERYX BIOPHARMS
- Local brand name: AURYXIA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 March 2026
- Application: ANDA212563
- Marketing authorisation holder: TEVA PHARMS USA
- Status: approved
Auryxia in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Auryxia approved in United States?
Yes. FDA authorised it on 5 September 2014; FDA authorised it on 5 September 2014; FDA authorised it on 11 March 2026.
Who is the marketing authorisation holder for Auryxia in United States?
KERYX BIOPHARMS holds the US marketing authorisation.