FDA Approves Otsuka & Lundbeck’s Once-Every-Two-Months Abilify Asimtufii®, LAI Antipsychotic For Schizophrenia Or Bipolar Disorder

The U.S. Food and Drug Administration (FDA) approved a New Drug Application (NDA) submitted by Otsuka America Pharmaceutical, Inc. and Lundbeck for Abilify Asimtufii, a long-acting antipsychotic injection (LAI) administered once every two months. The medication, a formulation of aripiprazole, was approved for treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults.

Abilify Asimtufii offers two months of sustained therapeutic concentrations with one dose. Each dose is provided in a single-chamber, prefilled syringe (960 mg and 720 mg prefilled syringes), and is administered by a healthcare professional to appropriate patients . . .