Posted by Michael Wonder on 06 Apr 2021
Acadia Pharmaceuticals receives complete response letter from U.S. FDA for supplemental new drug application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis
5 April 2021 - Acadia Pharmaceuticals today announced that the Company has received a complete response letter from the U.S. FDA regarding its supplemental new drug application for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis.
The FDA issued a complete response letter to indicate that they have completed their review of the application and has determined that the application cannot be approved in its present form.
