The FDA has approved a new drug application for aripiprazole, an extended-release injection for the treatment of schizophrenia and bipolar disorder, according to a press release from the manufacturers.
The approval is based on positive results from a 32-week randomized, parallel-arm multicenter study that included 266 participants with schizophrenia and bipolar I disorder, according to the release.
Specifically, the aripiprazole intramuscular injection (Abilify Asimtufii, Otsuka America Pharmaceutical and H. Lundbeck A/S) is indicated as a treatment for schizophrenia in adults or as a