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BioWorld - Saturday, February 14, 2026
Home » Rexulti

Articles Tagged with ''Rexulti''

Elderly man with clenched hands holding head

US FDA approves Rexulti as first drug for agitation in Alzheimer’s dementia

May 16, 2023
By Tamra Sami and Karen Carey
On its May 10 PDUFA date, the U.S. FDA approved serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s dementia, marking the first approved treatment for the indication.
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Elderly man with clenched hands holding head

US FDA approves Rexulti as first drug for agitation in Alzheimer’s dementia

May 11, 2023
By Tamra Sami and Karen Carey
On its May 10 PDUFA date, the U.S. FDA approved serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s dementia, marking the first approved treatment for the indication.
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Benefits of doubt: Rexulti from Otsuka/Lundbeck wins adcom thumbs-up, with nod to risk, in AD agitation

April 18, 2023
By Randy Osborne
As expected, the serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s disease (AD) dementia, found favor April 14 at the joint meeting of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee.
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Benefits of doubt: Rexulti from Otsuka/Lundbeck wins adcom thumbs-up, with nod to risk, in AD agitation

April 14, 2023
By Randy Osborne
As expected, the serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s disease (AD) dementia, found favor April 14 at the joint meeting of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee.
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Taking inventory of CMAI, adcom briefing docs add up to favor Otsuka/Lundbeck’s Rexulti in AD agitation

April 12, 2023
By Randy Osborne
Briefing documents suggest smooth sailing for Rexulti (brexpiprazole) at the meeting to deliberate an application to expand the label of the compound from Otsuka Pharmaceutical Co. Ltd. and Lundbeck A/S into agitation related to Alzheimer’s disease (AD) dementia. A joint sit-down on April 14 of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee will take up the matter of an add-on indication for Rexulti, a serotonin-dopamine activity modulator for schizophrenia and for the adjunctive treatment of major depressive disorder.
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