Lundbeck and Otsuka submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD
Valby, Denmark and Tokyo, Japan, – H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) have submitted a supplemental New Drug Application (sNDA) for U.S. Food and Drug Administration (FDA) review of brexpiprazole as combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD) in adults. FDA validation of the submission dossier prior to the FDA’s decision whether to proceed with a full review is expected to take 60 or 74 days depending on whether FDA assigns priority or standard review. The sNDA submission is based on previously