Prevents postoperative nausea and vomiting (PONV). NDA 209510, held by Lxo Ireland. Amisulpride.
As of Nov 13, 2026, NDA 209510 (Barhemsys), held by Lxo Ireland, was first approved by FDA on Feb 26, 2020, with 4 approved supplements and 2 published complete response letters.
BARHEMSYS is indicated in adults for: prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis. BARHEMSYS is a dopamine-2 (D 2 ) antagonist indicated in adults for: Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 26, 2020 | Original applicationNew molecular entity · Standard review | Approved |
| May 2, 2019 | Barhemsys (amisulpride)Product Quality/ Facility Inspections | Approved |
| Oct 5, 2018 | Barhemsys (amisulpride)Product Quality/Facility Inspection Deficiencies | Approved |
| Barhemsys5MG/2ML (2.5MG/ML) · solution;intravenous | Amisulpride | RxReference drug |
| Barhemsys10MG/4ML (2.5MG/ML) · solution;intravenous | Amisulpride | RxReference drug |
| Sep 14, 2022 | Supplement 5Labeling · Standard review | Approved | |
| Jan 5, 2022 | Supplement 4Labeling · Standard review | Approved | |
| May 25, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Sep 1, 2020 | Supplement 2Manufacturing | Approved | |
| Feb 26, 2020 | 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
