Food and Drug Administration

Psychopharmacological Drugs Advisory Committee

November 4, 2002

Slides

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Clozaril® (Clozapine) and Suicidality in Schizophrenia or Schizoaffective Disorder, Dr. Thomas Laughren, MD, FDA (HTM) (PPT)

Clozaril® (clozapine), Introduction and Overview, Roy Dodsworth, Novartis Pharmaceuticals Corp. (HTM) (PPT)

Suicidal Behavior in Schizophrenia and Schizoaffective Disorder, Dr. Herbert Meltzer, MD, Vanderbilt University (HTM) (PPT)

International Suicide Prevention Trial InterSePT, Study Design Efficacy and Safety Results, Dr. Rocco Zaninelli, MD, Novartis Pharmaceuticals Corp. (HTM) (PPT)

Benefit/Risk Assessment for Use of Clozaril in the Treatment of Emergent Suicidal Behavior, Dr. John Kane, MD, The Zucker Hillside Hospital (HTM) (PPT)

Supportive Slides, Novartis Pharmaceuticals Corp. (HTM) (PPT)

Clinical Inspection Summary, Dr. NI Khin, MD, FDA (HTM) (PPT)

Open Public Hearing

Clozaril® Proposed for the Treatment of Suicidality in Patients With Schizophrenia and Schizoaffective Disorder, James McNulty, National Alliance for the Mentally Ill (PDF)

Letter to Dr. Titus Regarding Application No. S047:Supplemental Drug Application From Novartis, Dr. Lynn Golgmam, MD, Johns Hopkins Bloomberg School of Public Health, et.al.(PDF)