BRIEF—FDA accepts Acacia Pharma re-filed Barhemsys NDA

UK-based hospital products firm Acacia Pharma says that the US Food and Drug Administration has accepted its resubmission of the New Drug Application (NDA) for Barhemsys (amisulpride injection) as a complete response, addressing the deficiencies identified in the October 5 complete response letter.

The CRL raised deficiencies relating to the pre-approval inspection of the contract facility employed to manufacture amisulpride.

The FDA has classified the resubmission as Class 2 and has given a Prescription Drug User Fee Act (PDUFA) goal of reviewing and acting on it no later than May 5, 2019. The company continues to plan for a launch in the first half of 2019.

“We are confident in our NDA resubmission for Barhemsys and are unwavering in our commitment to provide this new treatment option to surgical patients, their physicians and healthcare providers,” said Dr Julian Gilbert, chief executive of Acacia Pharma.