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Approved Risk Evaluation and Mitigation Strategies (REMS)

Clozapine
Shared System REMS
REMS last update: 09/29/2023

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
Clozaril (clozapine) ( PI at DailyMed , Info at Drugs@FDA ) NDA 019758 HERITAGE LIFE 09/15/2015 5f0c6f5f-b906-4c8f-8580-3939a476a1c1 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=019758
Versacloz (clozapine) ( PI at DailyMed , Info at Drugs@FDA ) NDA 203479 TASMAN PHARMA 09/15/2015 693cb9d4-39db-4ecf-9eae-b01f06f8d5d1 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203479
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 203807 DR REDDYS LABS SA 09/17/2015 339eedf1-6c19-46e0-be8f-3a58ea4d49d3 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203807
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 090308 BARR LABS INC 11/25/2015 6fccf4f7-2e30-4272-9800-225aaef20584 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090308
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 203039 TEVA PHARMS USA 11/25/2015 00f15108-4c15-4bf3-9665-dc32e5299006 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203039
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 202873 ACCORD HLTHCARE 11/25/2015 25c0c6d5-f7b0-48e4-e054-00144ff8d46c http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202873
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 206433 AUROBINDO PHARMA 11/29/2016 5021d643-32d2-4167-b5d8-90870e68a787 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=206433
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 075713 SUN PHARM INDS INC 09/15/2015 53bdb79c-c4cf-4818-b1f0-225e67a14536 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=075713
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 201824 MYLAN 09/15/2015 9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b219 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=201824
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 075417 MYLAN 09/15/2015 883b5d43-0339-7dc1-f775-93791fb9b978 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=075417
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 074949 IVAX SUB TEVA PHARMS 09/15/2015 47c4897c-ee95-4eaf-adbc-84130d021d2d http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=074949
clozapine ( PI at DailyMed , Info at Drugs@FDA ) ANDA 076809 IVAX SUB TEVA PHARMS 09/15/2015 47c4897c-ee95-4eaf-adbc-84130d021d2d http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076809

What is the purpose of the REMS?

The goal of the Clozapine REMS Program is to mitigate the risk of severe neutropenia associated with the use of clozapine by:

  1. Educating prescribers and pharmacists about the risk of severe neutropenia and appropriate monitoring requirements.
  2. Informing patients about the risk of severe neutropenia and appropriate monitoring requirements.
  3. Ensuring prescribers submit documentation that periodic monitoring of patients is performed to identify severe neutropenia
  4. Ensuring the prescriber documents a risk-benefit assessment when ANC falls below the acceptable range as described in the Prescribing Information.
  5. Establishing long-term safety and safe use of clozapine by enrolling all patients who receive clozapine in the registry.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

View additional drug-specific postmarket safety information from the FDA

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
09/29/2023 Updates to reflect a change in application ownership
11/10/2021 Modified to make changes to the hours of operations for the Clozapine REMS Contact Center.
07/29/2021 Modified to:
  1. make changes to the frequency of the submission of patient monitoring via a new Patient Status Form and make changes to the pharmacy operations to verify safe use conditions for a REMS dispense authorization
  2. revise the third goal to read from "ensuring compliance with the monitoring schedule for absolute neutrophil count (ANC) prior to dispensing clozapine" to "ensuring prescribers submit documentation that periodic monitoring of patients is performed to identify severe neutropenia"
02/18/2021 Modified to:
  1. remove reference to Fazaclo (clozapine) and Jazz Pharmaceuticals Inc. from the following materials:
    1. Clozapine and Risk of Neutropenia: A Guide for Healthcare Providers
    2. Clozapine REMS Website
  2. add a previously approved generic formulation for orally disintegrating tablet produced by Teva (ANDA203039) to the generic products table on the REMS website
11/12/2019 Revised to reflect editorial changes.
01/16/2019 Modified to incorporate the addition of educational materials, changes to the inpatient prescriber certification requirements and patient monitoring, and initiating the operational restrictions for prescriber and pharmacy certification.
09/15/2015 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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