BRIEF—Acacia to resubmit for US Barhemsys approval

UK-based Acacia Pharma says it plans to resubmit for US approval for Barhemsys (amisulpride injection), after meeting with the US regulator.

The firm agreed a plan for resubmission with the US Food and Drug Administration, designating a new supplier of the active pharmaceutical ingredient (API), amisulpride.

Chief executive Julian Gilbert said the firm now has “a clear path to resubmit the Barhemsys NDA in the third quarter of this year.”

“We expect a six-month review by the FDA, which would give a projected PDUFA date in the first quarter of 2020,” he added.