For severe diarrhea-predominant irritable bowel syndrome (IBS). NDA 21107, held by Legacy. Alosetron Hydrochloride.
As of Nov 13, 2026, NDA 21107 (Lotronex), held by Legacy, was first approved by FDA on Feb 9, 2000, with 20 approved supplements and 0 published complete response letters.
LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: chronic IBS symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and not responded adequately to conventional therapy. Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following: frequent and severe abdominal pain/discomfort, frequent bowel urgency or fecal incontinence, disability or restriction of daily activities due to IBS.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 1, 2008 | Supplement 13Efficacy (new indication or use) | Approved | |
| Jan 31, 2005 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Jun 7, 2002 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Feb 9, 2000 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| LotronexEQ 1MG BASE · tablet;oral | Alosetron Hydrochloride | RxReference drug |
| LotronexEQ 0.5MG BASE · tablet;oral | Alosetron Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 8, 2023 | Supplement 30REMS | Approved | |
| Apr 3, 2019 | Supplement 29Labeling · Standard review | Approved | |
| Jan 7, 2016 | Supplement 27Labeling · Standard review | Approved | |
| Jan 7, 2016 | Supplement 26REMS | Approved | |
| Jul 24, 2015 | Supplement 25REMS | Approved | |
| May 8, 2014 | Supplement 24REMS | Approved | |
| Apr 19, 2013 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Sep 2, 2010 | Supplement 16Labeling | Approved | |
| Sep 2, 2010 | Supplement 14Labeling · Standard review | Approved | |
| Apr 1, 2008 | Supplement 13Efficacy (new indication or use) | Approved | |
| Mar 10, 2006 | Supplement 12Labeling · Standard review | Approved | |
| Feb 18, 2005 | Supplement 11Labeling · Standard review | Approved | |
| Feb 4, 2005 | Supplement 10Labeling · Standard review | Approved | |
| Jan 31, 2005 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Dec 23, 2003 | Supplement 8Manufacturing · Priority review | Approved | |
| Mar 20, 2003 | Supplement 7Labeling · Standard review | Approved | |
| Jun 7, 2002 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Jun 3, 2002 | Supplement 6Manufacturing · Priority review | Approved | |
| Aug 11, 2000 | Supplement 2Labeling · Standard review | Approved | |
| Mar 7, 2000 | Supplement 1Manufacturing · Priority review | Approved | |
| Feb 9, 2000 | 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
