News & Media

Tokyo, Japan and Copenhagen, Denmark – July 14, 2014 – Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S, today announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for brexpiprazole for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD). The clinical development program for

Special Protocol Assessment for trial design and planned analysis agreed upon by the U.S. Food & Drug Administration220 worldwide sites to enroll approximately 1,300 patients with ADPKDPrinceton, N.J. – June 11 2014 – Otsuka Pharmaceutical Development & Commercialization, Inc., announced today that patient enrollment has begun for a new Phase 3b study of tolvaptan for adult patients

Princeton, N.J., and Valby, Denmark – April 30, 2014 – Otsuka America Pharmaceutical, Inc. (OAPI) and H.Lundbeck A/S (Lundbeck) today announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the proposed expanded labeling of Abilify Maintena (aripiprazole) for extended-release injectable suspension to support broader use of

Otsuka has acquired rights from Eisai Inc. to develop and sell in the US, Canada and Japan the DNA methylation inhibitor Dacogen®. In addition, Otsuka has acquired licensing rights worldwide, excluding Mexico. The drug is an intravenous formulation of decitabine (generic name) used in the treatment of myelodysplastic syndrome (MDS), in which ineffective or abnormal production of the myeloid