Treats travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli. NDA 21361, held by Salix Pharms. Rifaximin.
As of Nov 15, 2026, NDA 21361 (Xifaxan), held by Salix Pharms, was first approved by FDA on May 25, 2004, with 13 approved supplements and 0 published complete response letters.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
| May 27, 2015 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| May 25, 2004 | Original applicationNew molecular entity · Standard review | Approved |
| Oct 19, 2023 | Supplement 31Labeling · Standard review | Approved | |
| Oct 19, 2022 | Supplement 29Labeling · Standard review | Approved | |
| Nov 6, 2020 | Supplement 25Labeling · Standard review | Approved | |
| Dec 18, 2017 | Supplement 23Labeling · Standard review | Approved | |
| Jan 6, 2017 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jun 16, 2016 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Oct 15, 2015 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| May 27, 2015 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Apr 23, 2015 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 12, 2014 | Supplement 13Labeling · Standard review | Approved | |
| Nov 15, 2010 | Supplement 9Labeling · Standard review | Approved | |
| Mar 3, 2010 | Supplement 11Labeling | Approved | |
| Jan 30, 2007 | Supplement 6Labeling · Standard review | Approved | |
| May 25, 2004 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
