🇺🇸 Rifaximin (drug) in United States

FDA authorised Rifaximin (drug) on 25 May 2004

Marketing authorisations

FDA — authorised 25 May 2004

  • Application: NDA021361
  • Marketing authorisation holder: SALIX PHARMS
  • Local brand name: XIFAXAN
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 24 March 2010

  • Application: NDA022554
  • Marketing authorisation holder: SALIX PHARMS
  • Local brand name: XIFAXAN
  • Indication: TABLET — ORAL
  • Status: approved

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Other Gastroenterology / Infectious Disease approved in United States

Frequently asked questions

Is Rifaximin (drug) approved in United States?

Yes. FDA authorised it on 25 May 2004; FDA authorised it on 24 March 2010.

Who is the marketing authorisation holder for Rifaximin (drug) in United States?

SALIX PHARMS holds the US marketing authorisation.