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JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for

New efficacy data reported for pivotal Study 213 shows significant, clinically meaningful improvements in agitation symptoms.Agitation symptoms negatively impact functioning, disease progression, quality of life and care for about half of Alzheimer’s dementia patients – and are a consistent predictor of nursing home. ....

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Otsuka and Lundbeck Announce FDA Acceptance and Priority Review of sNDA for Brexpiprazole for the Treatment of Agitation Associated With Alzheimer's Dementia

Otsuka and Lundbeck Announce FDA Acceptance and Priority Review of sNDA for Brexpiprazole for the Treatment of Agitation Associated With Alzheimer's Dementia
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Aripiprazole 2-Month Under Review for Schizophrenia, Bipolar I Disorder

The FDA has accepted the NDA for aripiprazole 2-month, ready-to-use, long-acting injectable for schizophrenia and bipolar I disorder in adults. ....

Johan Luthman , Lundbeck Research Development , Drug Administration , New Drug Application , Lundbeck Research , Prescription Drug User Fee Act ,

Aripiprazole 2-Month Under Review for Schizophrenia, Bipolar I Disorder

The FDA has accepted the NDA for aripiprazole 2-month, ready-to-use, long-acting injectable for schizophrenia and bipolar I disorder in adults. ....

Johan Luthman , Lundbeck Research Development , Drug Administration , New Drug Application , Lundbeck Research , Prescription Drug User Fee Act ,