PARNATE (tranylcypromine sulfate)
PARNATE is indicated for the treatment of Major Depressive Disorder.
How PARNATE Works
Parnate functions as an irreversible inhibitor of the enzyme monoamine oxidase (MAO). While its exact mechanism as an antidepressant is not fully understood, it is presumed to work by increasing the activity of monoamine neurotransmitters in the central nervous system. By blocking the MAO enzyme, the drug potentiates these neurotransmitters to produce its therapeutic effect.
Details
- Status
- Prescription
- First Approved
- 1961-02-21
- Routes
- ORAL
- Dosage Forms
- TABLET
PARNATE Approval History
What PARNATE Treats
1 indicationsPARNATE is approved for 1 conditions since its original approval in 1961. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
PARNATE Boxed Warning
SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [ see Warnings and Precautions (5.1) ]. PARNATE is not approved for use in pediatric patients [ see Use in Specific Popula...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [ see Warnings and Precautions (5.1) ]. PARNATE is not approved for use in pediatric patients [ see Use in Specific Populations (8.4) ]. Hypertensive Crisis with Significant Tyramine Use Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with PARNATE or after PARNATE discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of PARNATE and interacting drugs. Instruct patients to avoid ingestion of foods and beverages with high tyramine content [ see Warnings and Precautions (5.2) and Drug Interactions ( 7.1 , 7.2 )]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS AND HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. PARNATE is not approved for use in pediatric patients. ( 5.1 , 8.4 ) Excessive consumption of foods or beverages with significant tyramine content or certain drugs can precipitate hypertensive crisis. Monitor blood pressure, allow for medication free intervals, and advise patients to avoid foods and beverages with high tyramine content. ( 5.2 , 7.1 , 7.2 )
PARNATE Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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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.
PARNATE FDA Label Details
Indications & Usage
FDA Label (PDF)PARNATE is indicated for the treatment of Major Depressive Disorder.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.