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BRIEF-Lundbeck Announces FDA Acceptance And Priority Review Of sNDA For Brexpiprazole For Treatment Of Agitation Associated With Alzheimer's Dementia

Reuters · 01/07/2023 09:34
BRIEF-Lundbeck Announces FDA Acceptance And Priority Review Of sNDA For Brexpiprazole For Treatment Of Agitation Associated With Alzheimer's Dementia

- H Lundbeck A/S HLUNb.CO:

  • LUNDBECK ANNOUNCES FDA ACCEPTANCE AND PRIORITY REVIEW OF SNDA FOR BREXPIPRAZOLE FOR TREATMENT OF AGITATION ASSOCIATED WITH ALZHEIMER'S DEMENTIA

  • FDA TARGET DATE (PDUFA DATE) FOR COMPLETION OF REVIEW IS MAY 10, 2023

  • BREXPIPRAZOLE ALSO DEMONSTRATED A GENERALLY FAVORABLE SAFETY AND TOLERABILITY PROFILE IN STUDIES

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Further company coverage: HLUNb.CO


((Reuters.Briefs@thomsonreuters.com;))