News & Media

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S 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.

Otsuka America Pharmaceutical, Inc. is voluntarily recalling certain ABILIFY® (aripiprazole) Tablets in the United States due to cross-contamination from extremely small amounts of another active pharmaceutical ingredient manufactured on the same equipment. The ABILIFY® (aripiprazole) Tablets affected are the 5 mg, 10 mg, 15 mg, and 30 mg doses. The 2 mg and 20 mg doses are not affected. Based on sample testing performed, there is no material patient risk associated with the level of contamination found. The detected amount of the ingredient was confirmed to be extremely small and significantly below the permitted daily exposure (PDE) established by the U.S. Food and Drug Administration (FDA). The voluntary recall has been initiated by Otsuka in the United States out of an abundance of caution, with the knowledge of the U.S. Food and Drug Administration (FDA).  This recall is limited to the United States. 

Otsuka Pharmaceutical Development & Commercialization, Inc. announces the launch of My Mental Health Journey, a longitudinal registry study that aims to advance research in depression and mental health. Verily Life Sciences LLC (Verily), a precision health technology company, will recruit participants and run the study. 

Otsuka Pharmaceutical, Co. Ltd. and Click Therapeutics, Inc., announce that the U.S. Food and Drug Administration  has cleared Rejoyn™ (developed as CT-152), the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication. Rejoyn is intended to reduce MDD symptoms.