Posted by Michael Wonder on 26 Sep 2019
Acacia Pharma announces new Barhemsys PDUFA target date of 26 February 2020
26 September 2019 - This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
Acacia Pharma Group announces that the US FDA has accepted its resubmitted new drug application for Barhemsys (amisulpride injection).
FDA has classified the resubmission as Class 2 and has given a Prescription Drug User Fee Act goal of reviewing and acting on it no later than 26 February 2020.
As part of this process, Acacia Pharma has nominated an alternative contract manufacturer to supply amisulpride, the active pharmaceutical ingredient in Barhemsys.
