Acacia Pharma receives complete response letter from FDA for Barhemsys

Acacia Pharma

3 May 2019 - Acacia Pharma announces that it has received a second complete response letter from the US FDA regarding its new drug application for Barhemsys (amisulpride injection). 

The letter identified continuing deficiencies at the contract manufacturer of amisulpride, the active pharmaceutical ingredient used in Barhemsys.

As previously, no concerns were raised by FDA on any of the clinical or non-clinical data in the NDA and no further studies or data analyses will be required for approval.

Read Acacia Pharma press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Dossier