Posted by Michael Wonder on 07 Nov 2018
Acacia Pharma resubmits Barhemsys new drug application
6 November 2018 - Acacia Pharma announces that it has resubmitted its new drug application for Barhemsys (amisulpride injection) to the US FDA.
On 8 October, the Company announced that it had received a complete response letter identifying deficiencies relating to the pre-approval inspection of the contract facility employed to manufacture amisulpride, the active pharmaceutical ingredient in Barhemsys. No defects were noted in the purity or stability of the active ingredient, or in the manufacturing process or quality of the finished product. In addition, no concerns were raised by FDA on any of the clinical or non-clinical data in the application and no further studies or data analyses will be required for approval.
