FDA — authorised 15 October 2015
- Application: NDA021361
- Marketing authorisation holder: SALIX PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Xifaxan in United States
FDA authorised Xifaxan on 15 October 2015
Marketing authorisation
Xifaxan in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Gastroenterology approved in United States
Frequently asked questions
Is Xifaxan approved in United States?
Yes. FDA authorised it on 15 October 2015.
Who is the marketing authorisation holder for Xifaxan in United States?
SALIX PHARMS holds the US marketing authorisation.