Cambridge, UK and Indianapolis, US – 26 September 2019: Acacia Pharma Group plc (“Acacia Pharma” or “the Company”), a pharmaceutical company developing and commercializing hospital products for US and international markets, announces that the US Food and Drug Administration (FDA) has accepted its resubmitted New Drug Application (NDA) for BARHEMSYS® (amisulpride injection). 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 26 February 2020.
As part of this process, Acacia Pharma has nominated an alternative contract manufacturer to supply amisulpride, the active pharmaceutical ingredient (API) in BARHEMSYS. The new supplier has extensive experience both in manufacturing amisulpride and in producing APIs to the standards required by FDA. The supplier has also successfully undergone and passed regular inspections by regulatory authorities for compliance with current Good Manufacturing Practices (cGMP).
“We are very pleased the FDA has accepted the resubmission of our application and granted us a Q1 PDUFA date, as we anticipated. Our team has worked very hard qualifying a new supplier of amisulpride for our application and I am delighted how quickly this has been achieved. Given the proven track record of our new supplier, we are very confident of success in this review period and our commercial team is well positioned to launch BARHEMSYS in the USA next year,” said Acacia Pharma CEO, Mike Bolinder.
Contacts
Acacia Pharma Group plc
Mike Bolinder, CEO
Christine Soden, CFO
+44 1223 919760
IR@acaciapharma.com