Food and Drug Administration

Psychopharmacologic Drugs Advisory Committee

June 16, 2003

Clozar il® (clozapine) Tablets


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.

Backgrounder Information on Clozaril® (clozapine) Tablets, Novartis Pharmaceuticals Corp. (HTM) (PDF) (Word)

Appendix I: Post-Text Tables (United States Data), Novartis Pharmaceuticals Corp. (HTM) (PDF) (Word)

Appendix II: Post-Text Tables (United Kingdom Data), Novartis Pharmaceuticals Corp. (HTM) (PDF) (Word)

Appendix III: Post-Text Tables (Australian Data), Novartis Pharmaceuticals Corp. (HTM) (PDF) (Word)

Appendix IV: Method for Estimating the Rates of Agranulocytosis and Severe Leukopenia if the Current Bi-weekly Monitoring Option of WBC Counts After Six Months of Treatment with Clozaril is Changed to a Less Frequent Monitoring Option, Novartis Pharmaceuticals Corp. (HTM) (PDF) (Word)

Appendix V: Summary of Fatal Outcomes Associated With Clozaril and the Development of Agranulocytosis Events Under Initial Monitoring System, Novartis Pharmaceuticals Corp. (HTM) (Excel)

Appendix VI: Algorithm for Criteria in Monitoring Frequency in the United States, United Kingdom, and Australia, Novartis Pharmaceuticals Corp. (HTM) (PDF) (Word)

Overview of the Effect of the WBC Monitoring Schedule on the Rate of Clozapine-Associated Agranulocytosis - Cover Memorandum, FDA (HTM) (PDF) (Word)

Review and Evaluation of Clinical Data, FDA (HTM) (PDF) (Word)

Review of a Report from Novartis on the Usefulness of Clozaril National Patient Registry to Model the Risk of Agranulocytosis and Severe Leukopenia Under Different Monitoring Frequencies, FDA (HTM) (PDF) (Word)