FDA Accepts Otsuka and Lundbeck’s NDA for Long-Acting Aripiprazole

September 19, 2022

The FDA has accepted Otsuka and Lundbeck’s New Drug Application (NDA) for its long-acting, two-month injectable version of aripiprazole for the treatment of adults with schizophrenia and for maintenance monotherapy treatment of adults with bipolar I disorder.

The antipsychotic treatment under the NDA is intended for dosing every two months through intramuscular injection in the gluteal muscle.

The NDA is supported by results from a clinical trial in which the treatment demonstrated similarity in aripiprazole plasma concentrations to aripiprazole once-monthly 400 mg over a two-month dosing interval.

The FDA target date for completion of the NDA review is April 27, 2023.

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