Otsuka and Lundbeck’s sNDA for Rexulti gains US FDA approval
Pharmaceutical Technology
MAY 11, 2023
Otsuka Pharmaceutical and H Lundbeck have received approval for the supplemental new drug application (sNDA) from the US Food and Drug Administration for Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease. The regulator accepted and gr anted priority review for the sNDA in January 2023.
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