FDA acceptance of NDA filing for Baremsis for the management of post-operative nausea & vomiting

Acacia Pharma

4 January 2018 - If approved, Baremsis would be the first antiemetic with an indication for rescue treatment of post-operative nausea & vomiting after failed prophylaxis, and combination prophylaxis of PONV with standard anti-emetics.

Acacia Pharma announces that the new drug application for Baremsis (amisulpride injection, formerly APD421) for the management of post-operative nausea & vomiting, has been accepted for filing by the US FDA. 

Under the Prescription Drug User Fee Act, the FDA has set a target date of 5 October 2018 to complete its review.

Read Acacia Pharma press release


Michael Wonder

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Michael Wonder

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Medicine , US , Dossier