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Barhemsys FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 8, 2020.

FDA Approved: Yes (First approved February 26, 2020)
Brand name: Barhemsys
Generic name: amisulpride
Dosage form: Injection
Company: Acacia Pharma
Treatment for: Nausea/Vomiting, Postoperative

Barhemsys (amisulpride) is a dopamine-2 (D2) antagonist for the management of post-operative nausea and vomiting (PONV).

Development timeline for Barhemsys

DateArticle
Feb 27, 2020Approval FDA Approves Barhemsys (amisulpride) for the Treatment and Prevention of Postoperative Nausea and Vomiting
Sep 26, 2019Acacia Pharma Announces New Barhemsys PDUFA Target Date
Jul  8, 2019Acacia Pharma Plans to Resubmit the Barhemsys NDA in Q3 2019
May  3, 2019Complete Response Letter from FDA for Barhemsys
Dec  7, 2018New Barhemsys PDUFA Date Confirmed for 5 May 2019
Nov  6, 2018Acacia Pharma Resubmits Barhemsys New Drug Application
Oct  8, 2018FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys
Sep 14, 2018Positive Barhemsys Phase 3 Treatment Data Published in Anesthesia & Analgesia
Jan  4, 2018Acacia Pharma Announces FDA Acceptance of NDA Filing For Baremsis for the Management of Post-Operative Nausea & Vomiting

Further information

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