Posted by Michael Wonder on 26 Jun 2024
Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder
25 June 2024 - The FDA target date (PDUFA date) for completion of the review is 8 February 2025.
Otsuka and Lundbeck announce the US FDA has determined that the supplemental new drug application for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder is sufficiently complete to permit a substantive review.
