CLOZAPINE
Details
- Status
- Prescription
- First Approved
- 1996-08-30
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING, TABLET
Companies
CLOZAPINE Approval History
What CLOZAPINE Treats
14 FDA approvalsOriginally approved for its first indication in 1996 . Covers 14 distinct patient populations.
- Other (14)
Other
(14 approvals)- • Approved indication (Aug 1996)
- • Approved indication (Nov 1997)
- • Approved indication (May 1999)Letter
- • Approved indication (Nov 2002)
- • Approved indication (Apr 2005)
- • Approved indication (Dec 2005)
- • Approved indication (Apr 2010)Letter
- • Approved indication (Sep 2015)Letter
- • Approved indication (Sep 2015)
- • Approved indication (Nov 2015)Letter
- • Approved indication (Nov 2016)Letter
- • Approved indication (Dec 2017)Letter
- • Approved indication (Apr 2018)Letter
- • Approved indication (Dec 2024)
CLOZAPINE Boxed Warning
SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS, PERICARDITIS, AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Severe Neutropenia Clozapine tablets have caused severe neutropenia which is associated with an increased risk of serious and potentially fatal infections. Prior to initiating clozapine tablets treatment, obtain baseline ANC(s). Clozapine tablets initiation is not recommended in patients with a basel...
WARNING: SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS, PERICARDITIS, AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Severe Neutropenia Clozapine tablets have caused severe neutropenia which is associated with an increased risk of serious and potentially fatal infections. Prior to initiating clozapine tablets treatment, obtain baseline ANC(s). Clozapine tablets initiation is not recommended in patients with a baseline ANC less than 1500/μL (less than 1000/μL for those with Benign Ethnic Neutropenia (also known as Duffy-null associated neutrophil count)). See recommendations for dosage modifications based on ANC levels during clozapine tablets treatment [see Dosage and Administration (2.3 , 2.4) ] . Consider a hematology consultation before initiating clozapine tablets or during clozapine tablets treatment [see Warnings and Precautions (5.1) ] . Orthostatic Hypotension, Bradycardia, Syncope Orthostatic hypotension, bradycardia, syncope, and cardiac arrest have occurred with clozapine tablets treatment. The risk is highest during the initial titration period, particularly with rapid dose escalation. These reactions can occur with the first dose, with doses as low as 12.5 mg per day, or when restarting patients who have had even a brief interruption in treatment with clozapine tablets. Initiate treatment at 12.5 mg once or twice daily; titrate slowly; and use divided dosages to minimize risk. Use clozapine tablets cautiously in patients with cardiovascular or cerebrovascular disease or conditions predisposing to hypotension (e.g., dehydration, use of antihypertensive medications) [see Dosage and Administration (2.2 , 2.6) , Warnings and Precautions (5.2) ] . Seizures Seizures have occurred with clozapine tablets treatment. The risk is dose - related. Initiate treatment at 12.5 mg, titrate gradually, and use divided dosing. Use caution when administering clozapine tablets to patie
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CLOZAPINE FDA Label Details
ProIndications & Usage
Clozapine tablets are an atypical antipsychotic indicated for: Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, clozapine tablets should be used only in patients who have failed to respond adequately to standard antipsychotic treatment. Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior. 1.1 Treatment-Resistant...
WARNING: SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS, PERICARDITIS, AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Severe Neutropenia Clozapine tablets have caused severe neutropenia which is associated with...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.