News & Media

Otsuka Pharmaceutical, Co. Ltd. and Lundbeck LLC announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of REXULTI^® (brexpiprazole) for use in the treatment of agitation associated with dementia due to Alzheimer’s disease.

Otsuka America Pharmaceutical, Inc. and Lundbeck announce the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ABILIFY ASIMTUFII® (aripiprazole) extended-release injectable suspension for intramuscular use, a once-every-two-months injection for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults.

Sunovion Pharmaceuticals Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc. today announced that the first patient has been randomized in a Phase 2/3 clinical study evaluating ulotaront, a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT_1A agonist activity, for the treatment of generalized anxiety disorder (GAD). In addition to GAD, ulotaront is being investigated in late-stage clinical studies for the treatment of schizophrenia and for the adjunctive treatment of major depressive disorder (MDD).

Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck Pharmaceuticals LLC announce the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) met to discuss the supplemental New Drug Application (sNDA) of REXULTI® (brexpiprazole) for the treatment of agitation associated with Alzheimer’s dementia (AAD). The committee voted 9-1 that Otsuka and Lundbeck provided sufficient data to allow the identification of a population in whom the benefits of treating AAD with REXULTI outweigh its risks.