Otsuka Lun,dbeck FDA Accepts sNDA Filing forTreatment of 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 February 8, 2025.
• If approved, brexpiprazole and sertraline combination treatment would be the first FDA-approved pharmacological option for PTSD in more than 20 years.

https://www.biospace.com/article/releases/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-ptsd-/