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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

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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