EHS
EHS

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 than initially planned.
“There is significant unmet need for treatment options among pediatric schizophrenia patients, so we are pleased to submit this sNDA for Rexulti 1 year ahead of schedule with

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