Acacia Pharma Group plc (“Acacia Pharma” or “the Company”), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that the US Food and Drug Administration (FDA) has accepted its resubmission of the New Drug Application (NDA) for BARHEMSYS™ (amisulpride injection) as a complete response, addressing the deficiencies identified in the 5 October complete response letter. 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 5 May 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, CEO of Acacia Pharma.
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