FDA — authorised 7 December 2001
- Marketing authorisation holder: MYLAN IRELAND LTD
- Status: approved
🇺🇸 Arixtra in United States
FDA authorised Arixtra on 7 December 2001
Marketing authorisations
FDA — authorised 28 May 2004
- Application: NDA021345
- Marketing authorisation holder: MYLAN IRELAND LTD
- Indication: Efficacy
- Status: approved
FDA — authorised 19 March 2014
- Application: ANDA091316
- Marketing authorisation holder: DR REDDYS LABS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 26 December 2017
- Application: ANDA206918
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 15 May 2018
- Application: ANDA206812
- Marketing authorisation holder: HENGRUI PHARMA
- Status: approved
FDA — authorised 14 November 2018
- Application: ANDA208615
- Marketing authorisation holder: SCINOPHARM TAIWAN
- Status: approved
Arixtra in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Arixtra approved in United States?
Yes. FDA authorised it on 7 December 2001; FDA authorised it on 28 May 2004; FDA authorised it on 19 March 2014.
Who is the marketing authorisation holder for Arixtra in United States?
MYLAN IRELAND LTD holds the US marketing authorisation.