Posted by Michael Wonder on 08 Oct 2018
Acacia Pharma provides update on FDA regulatory review of Barhemsys
8 October 2018 - FDA issued a complete response letter to Acacia Pharma on Friday 5 October.
Acacia Pharma announces that it has received a complete response letter from the US FDA regarding its new drug application for Barhemsys (amisulpride injection).
The letter identified that deficiencies had been reported during a recent pre-approval FDA inspection of the contract manufacturer of amisulpride, the active pharmaceutical ingredient used in Barhemsys. No inadequacies were noted regarding the purity or stability of the active ingredient, or the manufacturing process or quality of the finished product.
