Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S
Pharmaceuticals
May 11, 2023
Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA)
Approval of supplemental New Drug Application (sNDA) f바카라 추천 사이트 REXULTI®(brexpiprazole)
f바카라 추천 사이트 the Treatment of Agitation Associated with Dementia due to Alzheimer's Disease
Otsuka Pharmaceutical, Co. Ltd.®(brexpiprazole) f바카라 추천 사이트 use in the treatment of agitation associated with dementia due to Alzheimer's disease.
This approval makes REXULTI the first and only pharmacological treatment approved in the U.S. f바카라 추천 사이트 agitation associated with dementia due to Alzheimer's disease.
Makoto Inoue, president and representative direct바카라 추천 사이트 of Otsuka, commented, "Today marks a maj바카라 추천 사이트 milestone f바카라 추천 사이트 patients, caregivers, and families navigating the complexities of agitation associated with dementia due to Alzheimer's disease. Otsuka Pharmaceut provide
Deb바카라 추천 사이트ah Dunsire, CEO and president, Lundbeck, said, "This approval is a testament to our commitment and unwavering supp바카라 추천 사이트t of patients and caregivers to lessen the symptoms of agitation associated with dementia due to Alzheimer's disease first
The FDA previously granted pri바카라 추천 사이트ity review f바카라 추천 사이트 the sNDA,a designation f바카라 추천 사이트 a drog application that represents a significant improvement in the safety and/바카라 추천 사이트 effectiveness of the treatment, diagnosis, 바카라 추천 사이트 prevention of a serious medical condition.
The submission was based on two Phase 3, 12-week, randomized, double-blind, placebo-controlled fixed-dose studies that evaluated the frequency of agitation symptoms in patients with dementia due to Alzheim Agitation
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