How the FDA approved an antipsychotic that failed to show a meaningful benefit but raised the risk of death

Author:

Whitaker Robert

Publisher

BMJ

Subject

General Engineering

Reference12 articles.

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2. DeArment A. Otsuka/Lundbeck’s Rexulti has time to build a lead in the Alzheimer’s agitation market. Scrip 2023 May 11. https://scrip.pharmaintelligence.informa.com/SC148364/OtsukaLundbecks-Rexulti-Has-Time-To-Build-A-Lead-In-The-Alzheimers-Agitation-Market

3. Food and Drug Administration. April 14, 2023: Joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee meeting announcement. 14 Apr 2023. https://www.fda.gov/advisory-committees/advisory-committee-calendar/april-14-2023-joint-meeting-psychopharmacologic-drugs-advisory-committee-and-peripheral-and-central

4. Food and Drug Administration. Meeting transcript: Joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee. 14 Apr 2023. https://www.fda.gov/media/169116/download

5. Agitation in Alzheimer's disease: Novel outcome measures reflecting the International Psychogeriatric Association (IPA) agitation criteria

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