For severe diarrhea-predominant irritable bowel syndrome (IBS). ANDA 213614, held by Mankind Pharma. Alosetron Hydrochloride.
As of Nov 15, 2026, ANDA 213614 (Alosetron Hydrochloride), held by Mankind Pharma, was first approved by FDA on Sep 9, 2020, with 4 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 |
|---|---|---|---|
| Sep 9, 2020 | Original application | Approved | None posted |
| Alosetron HydrochlorideEQ 0.5MG BASE · tablet;oral | Alosetron Hydrochloride | Rx |
| Alosetron HydrochlorideEQ 1MG BASE · tablet;oral | Alosetron Hydrochloride | Rx |
| Sep 8, 2023 | Supplement 17REMS | Approved | |
| May 26, 2022 | Supplement 7Labeling · Standard review | Approved | None posted |
| May 5, 2022 | Supplement 13REMS | Approved | None posted |
| Oct 18, 2021 | Supplement 10REMS | Approved | None posted |
| Sep 9, 2020 | Original application | Approved | None posted |
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
