Treats irritable bowel syndrome with diarrhea (IBS-D). NDA 206940, held by Abbvie. Eluxadoline.
As of Nov 13, 2026, NDA 206940 (Viberzi), held by Abbvie, was first approved by FDA on May 27, 2015, with 6 approved supplements and 0 published complete response letters.
VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 27, 2015 | Original applicationNew molecular entity · Priority review | Approved |
| Viberzi75MG · tablet;oral | Eluxadoline | RxReference drug |
| Viberzi100MG · tablet;oral | Eluxadoline | RxReference drug |
| Jun 17, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Jun 26, 2018 | Supplement 6Labeling · Standard review | Approved | |
| Apr 13, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Nov 8, 2017 | Supplement 5Labeling · Standard review | Approved | |
| Apr 20, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Feb 2, 2017 | Supplement 1Labeling · Standard review | Approved | |
| May 27, 2015 | Original applicationNew molecular entity · Priority 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
