FDA — authorised 25 May 2004
- Application: NDA021361
- Marketing authorisation holder: SALIX PHARMS
- Local brand name: XIFAXAN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 xifaxan in United States
FDA authorised xifaxan on 25 May 2004
Marketing authorisations
FDA — authorised 24 March 2010
- Application: NDA022554
- Marketing authorisation holder: SALIX PHARMS
- Local brand name: XIFAXAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 March 2026
- Application: ANDA208959
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: RIFAXIMIN
- Indication: TABLET — ORAL
- Status: approved
The FDA approved the application number ANDA208959 for RIFAXIMIN (Xifaxan) on 19 March 2026. This approval was granted to ACTAVIS LABS FL INC. The approved indication for RIFAXIMIN is for oral tablet administration. The approval was granted through the standard expedited pathway.
FDA
- Application: ANDA220451
- Marketing authorisation holder: ALKEM LABORATORIES LIMITED
- Local brand name: RIFAXIMIN
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA214369
- Marketing authorisation holder: NORWICH PHARMACEUTICALS INC
- Local brand name: RIFAXIMIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA218650
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: RIFAXIMIN
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA214370
- Marketing authorisation holder: NORWICH
- Local brand name: RIFAXIMIN
- Indication: TABLET — ORAL
- Status: approved
Other Infectious Disease approved in United States
Frequently asked questions
Is xifaxan approved in United States?
Yes. FDA authorised it on 25 May 2004; FDA authorised it on 24 March 2010; FDA authorised it on 19 March 2026.
Who is the marketing authorisation holder for xifaxan in United States?
SALIX PHARMS holds the US marketing authorisation.