Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part I: A Review of the Pharmacokinetic Literature and Proposed Changes.

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Title: Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part I: A Review of the Pharmacokinetic Literature and Proposed Changes.
Authors: de Leon J, Baldessarini RJ, Balon R; Departments of Psychiatry and Behavioral Neurosciences and Anesthesiology, Wayne State University, Detroit, MI., Bilbily J; Department of Psychiatry, Washington University in St. Louis, St. Louis, MO., Caroff SN, Citrome L; New York Medical College, Department of Psychiatry and Behavioral Sciences, Valhalla, NY., Correll CU, Cotes RO; Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA., Davis JM; Department of Psychiatry, University of Illinois at Chicago, Chicago, IL., DeLisi LE; Department of Psychiatry, Cambridge Health Alliance, Harvard Medical School, Cambridge, MA., Faden J; Department of Psychiatry, Lewis Katz School of Medicine at Temple University, Philadelphia, PA., Freudenreich O; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA., Goldsmith DR; Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA., Gurrera R, Josiassen RC; Translational Neuroscience LLC, Conshohocken, PA., Kane JM, Kelly DL; Maryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD., Keshavan MS; Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA., Laitman RS; Bronx Westchester Medical Group, Mount Kisco, NY., Lam YWF; Department of Pharmacology, University of Texas Health Science Center at San Antonio, San Antonio, TX., Leung JG; Department of Pharmacy, Mayo Clinic, Rochester, MI., Love RC; Department of Practice, Sciences, and Health Outcomes Research, University of Maryland School of Pharmacy, Baltimore, MD., McCollum B; Eastern State Hospital, Lexington, KY., McGrane IR; Department of Pharmacy Practice, University of Montana, Missoula, MT., Meyer J; Department of Psychiatry, University of California, San Diego, CA., Nasrallah HA; Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati, Cincinnati, OH., Nucifora FC Jr; Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, MD., Rothschild AJ; Department of Psychiatry, University of Massachusetts Chan Medical School and UMass Memorial HealthCare, Worcester, MA., Rubio JM, Sajatovic M; Department of Psychiatry and of Neurology, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, OH., Sarpal DK; Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA., Schoretsanitis G, Shad M; Department of Psychiatry, University of Nevada, Las Vegas, NV., Shelton C, Sher L; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY., Singh B; Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MI., Surya S; Department of Psychiatry and Health Behavior, Augusta University, Augusta, GA., Zarzar TR; Department of Psychiatry, University of North Carolina School of Medicine, Chapel Hill, NC., Sanz EJ, De Las Cuevas C; Department of Internal Medicine, Dermatology and Psychiatry, School of Medicine, and Instituto Universitario de Neurociencia (IUNE), University of La Laguna, Canary Islands, Spain.
Source: Journal of clinical psychopharmacology [J Clin Psychopharmacol] 2025 May-Jun 01; Vol. 45 (3), pp. 179-196. Date of Electronic Publication: 2025 Apr 09.
Publication Type: Journal Article; Review
Journal Info: Publisher: Williams And Wilkins Country of Publication: United States NLM ID: 8109496 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1533-712X (Electronic) Linking ISSN: 02710749 NLM ISO Abbreviation: J Clin Psychopharmacol Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1533-712X
DOI:10.1097/JCP.0000000000001987