Acacia provides update on plan to address PONV complete response letter

Acacia Pharma Group plc (Euronext:ACPH) said Oct. 15 that it will complete within one month a plan to address an undisclosed manufacturing deficiency identified by FDA that caused the agency to issue a complete response letter to an NDA for Barhemsys amisulpride.

Once the plan is completed, Acacia will resubmit the NDA, which is seeking approval of the low-dose IV formulation of amisulpride to treat and prevent postoperative nausea and vomiting. FDA will then have 30 days to indicate whether it will complete its review of the resubmitted NDA within 60 days or within six months. Acacia reiterated its plans to launch Barhemsys next half...