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Otsuka and Lundbeck Announce U.S. FDA Acceptance of New Drug Application for Aripiprazole 2-month, Ready-to-Use, Long-acting Injectable to Treat Schizophrenia and Bipolar I Disorder in Adults
Otsuka America Pharmaceutical, Inc., and H. Lundbeck A/S announce the U.S. Food and Drug Administration acceptance of their New Drug Application for aripiprazole 2-month, ready-to-use, long-acting injectable, a medication administered for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults. Aripiprazole 2-month, ready-to-use, long-acting injectable is provided in a single-chamber-type, prefilled syringe. It is intended for dosing every two months via intramuscular injection in the gluteal muscle.