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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 been reported during an inspection of a facility of the...

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