For severe diarrhea-predominant irritable bowel syndrome (IBS). ANDA 206647, held by Amneal Pharms. Alosetron Hydrochloride.
As of Nov 15, 2026, ANDA 206647 (Alosetron Hydrochloride), held by Amneal Pharms, was first approved by FDA on Dec 22, 2016, with 5 approved supplements and 0 published complete response letters.
Alosetron tablets are 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 |
|---|---|---|---|
| Dec 22, 2016 | Original application | Approved |
| Alosetron HydrochlorideEQ 0.5MG BASE · tablet;oral | Alosetron Hydrochloride | Rx |
| Alosetron HydrochlorideEQ 1MG BASE · tablet;oral | Alosetron Hydrochloride | Rx |
| Dec 8, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Sep 8, 2023 | Supplement 16REMS | Approved | |
| May 5, 2022 | Supplement 12REMS | Approved | None posted |
| Oct 18, 2021 | Supplement 9REMS | Approved | None posted |
| Dec 6, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 22, 2016 | Original application | 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
