Lundbeck and Otsuka announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD)
· The supplemental new drug application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) has been accepted and filed by the FDA · The FDA target date (PDUFA date) for completion of the review is 8 February 2025 · If approved, brexpiprazole and sertraline combination treatment would be the first FDA-approved pharmacological treatment for PTSD in more than 20 years Valby, Denmark, 25 June 2024 – H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announce the U.S. Food and Drug