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Another FDA 'No' For Acacia Over Unresolved Facility Deficiencies

 
• By Kevin Grogan

Confusion reigns at the UK firm as a second attempt to get approval for its nausea and vomiting treatment Barhemsys floundered following an insufficient resolution of manufacturing deficiencies at the supplier of the drug.

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More bad news for Acacia • Source: Shutterstock

Investors have lost patience with Acacia Pharma Ltd., sinking the UK firm's stock after it suffered a second rejection from the US Food and Drug Administration for the post-operative nausea and vomiting (PONV) therapy Barhemsys, once again as a result of problems at the contract drug manufacturer.

Acacia was hit with its first complete response letter from the FDA in October 2018 which identified deficiencies that had...

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