Undeterred Acacia resubmits Barhemsys NDA

Acacia Pharma (Euronext: ACPH) has wasted no time in resubmitting its New Drug Application (NDA) for Barhemsys (amisulpride injection) to the US Food and Drug Administration (FDA).

The UK-based drugmaker, which develops and commercializes hospital products for the US and international markets, received a complete response letter from the FDA relating to Barhemsys less than a month ago.

The letter raised deficiencies relating to the pre-approval inspection of the contract facility employed to manufacture amisulpride, the active pharmaceutical ingredient in Barhemsys, which is Acacia’s lead product and has positive Phase III results in post-operative nausea and vomiting.