FDA Accepts Application For Nuplazid To Treat Dementia-Related Psychosis

ACADIA Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA has assigned a standard review with Prescription Drug User Fee Act action date of April 3, 2021.

The FDA has also informed the company that it has not identified any potential review issues at this point in their evaluation and at this time they are not planning to hold an Advisory Committee meeting. The sNDA is supported by results . . .