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Barhemsys Approval Status

FDA Approved: No
Brand name: Barhemsys
Generic name: amisulpride
Dosage form: Injection
Previous Name: Baremsis
Company: Acacia Pharma
Treatment for: Nausea/Vomiting, Postoperative

Barhemsys (amisulpride) is a dopamine antagonist in development for the management of post-operative nausea & vomiting (PONV).

Development Status and FDA Approval Process for Barhemsys

DateArticle
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
May 29, 2012Acacia Pharma Announces Excellent Phase II Results for APD421 in Post-Operative Nausea & Vomiting

Further information

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