Posted by Michael Wonder on 08 Jan 2023
Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia
7 January 2023 - The FDA target date (PDUFA date) for completion of the review is 10 May 2023.
Otsuka and Lundbeck announce the US FDA has determined that the supplementary new drug application for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia is sufficiently complete to permit a substantive review.
