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FDA accepts supplemental new drug application for Rexulti

Otsuka and Lundbeck have announced FDA acceptance of a supplemental new drug application for Rexulti for the treatment of schizophrenia in adolescents. Rexulti (brexpiprazole, Otsuka/Lundbeck) is currently approved in the U.S. as a treatment for adults with schizophrenia and as an adjunctive treatment for adults with major depressive disorder. The application submission occurred 1 year earlier ....

Johan Luthman , Otsuka Lundbeck , Christoph Koenen , Psych Congress , Otsuka Pharmaceutical Development Commercialization Inc , Otsuka Pharmaceutical Development , Commercialization Inc ,