U.S. FDA Approves Dual-Chamber Syringe For Abilify Maintena® (Aripiprazole) Extended-Release Injectable Suspension For The Treatment Of Schizophrenia

PRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck announced today that the U.S. Food and Drug Administration (FDA) has approved a new formulation of Abilify Maintena® (aripiprazole) for extended-release injectable suspension – a pre-filled dual-chamber syringe. Abilify Maintena is an atypical antipsychotic indicated for the treatment of schizophrenia; efficacy was demonstrated in a placebo-controlled, randomized-withdrawal maintenance trial in patients with schizophrenia and additional support for efficacy was derived from oral aripiprazole trials. The companies expect the dual-chamber syringe will be available in the U.S. in January 2015.

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