Lucca01 schreef op 2 januari 2019 18:11:
Acacia Pharma in Cambridge has won FDA approval for a key play in the US. The company, which is listed on the Euronext Brussels exchange, is developing and commercialising hospital products for US and international markets.
It reveals that the US Food and Drug Administration has accepted its resubmission of the New Drug Application for BARHEMSYS™ (amisulpride injection) as a complete response, addressing the deficiencies identified in the October complete response letter.
The FDA has classified the resubmission as Class 2 and given a Prescription Drug User Fee Act (PDUFA) goal of reviewing and acting on it no later than May 5, 2019.
Acacia continues to plan for launch in the first half of 2019. CEO Julian Gilbert said: “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.”
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