The Psychopharmacologic Drugs Advisory Committee (PDAC) and the Peripheral and Central Nervous System Drugs Advisory Committee (PDAC) of the USFDA has scheduled a meeting on Friday, April 14th, 2023. During the meeting, the committee will discuss supplemental new drug application (sNDA 205422 s009), efficacy supplement for REXULTI (Brexpiprazole) tablets, submitted by Otsuka Pharmaceutical Company, Ltd., and Lundbeck, Inc., for the proposed treatment of agitation associated with Alzheimer’s dementia.
Back to All Events
Earlier Event: March 22
Peripheral and Central Nervous System Drugs Advisory Committee (PCNS)
Later Event: April 17
Antimicrobial Drug Advisory Committee (AMDAC)