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 |
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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:
- Educating prescribers and pharmacists about the risk of severe neutropenia and appropriate monitoring requirements.
- Informing patients about the risk of severe neutropenia and appropriate monitoring requirements.
- Ensuring prescribers submit documentation that periodic monitoring of patients is performed to identify severe neutropenia
- Ensuring the prescriber documents a risk-benefit assessment when ANC falls below the acceptable range as described in the Prescribing Information.
- 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
View additional drug-specific postmarket safety information from the FDA
What assessment is available to the REMS?
Assessment Plan |
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REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
Date | Summary of change |
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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:
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02/18/2021 | Modified to:
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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.