Acacia Pharma Ltd. – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Acacia Pharma Ltd for its New Drug Application (NDA) 209510 for Barhemsys (amisulpride) injection, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The letter, dated May 2, 2019, indicated that the application cannot be approved in its current form due to several outstanding deficiencies. A primary issue identified was unsatisfactory resolution of deficiencies observed during a recent inspection of a manufacturing facility. The FDA requires satisfactory resolution of these product quality issues before approval. Additionally, the FDA reserved comments on the proposed prescribing information, advising the company to review and update labeling to comply with regulatory requirements and submit it in structured product labeling (SPL) format. A comprehensive safety update is also required, including new nonclinical and clinical data, combined safety tabulations, detailed case reports for adverse events, and a summary of worldwide safety experience. While the proprietary name "Barhemsys" was found acceptable, it must be resubmitted with the company's full response. The FDA also recommended conducting a pharmacokinetic study to better characterize amisulpride's effects in patients with severe renal impairment, though this was not an approvability issue. Acacia Pharma has one year to resubmit a complete response addressing all identified deficiencies.