Acacia Pharma Group plc(“Acacia Pharma”), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that it has received a second Complete Response Letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) 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.
“We are extremely disappointed that the amisulpride manufacturer named in our application has still not been able to meet FDA’s required standards,” said Dr Julian Gilbert, CEO of Acacia Pharma. “As there were no other issues raised with our application, we remain confident that BARHEMSYS is approvable. We are on track to complete the qualification of an alternative supplier of amisulpride and plan to engage with FDA as soon as possible to determine the most rapid route to obtaining approval for BARHEMSYS.”
Conference Call Information
The Acacia Pharma management team will host a conference call Friday, 3 May 2019, at 14.00 CEST, 13:00 BST, 07:00 EST. Please join the event conference 5-10 min prior to the start using the confirmation code and any of the phone numbers provided below.
Password: Acacia Pharma
| Location | Phone Number |
| Belgium | 0800 746 68 |
| United Kingdom | 0808 109 0700 |
| United States | 1 866 966 5335 |
| International | +44 (0) 20 3003 2666 |
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