TRIENTINE HYDROCHLORIDE
Details
- Status
- Prescription
- First Approved
- 2018-02-07
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
TRIENTINE HYDROCHLORIDE Approval History
What TRIENTINE HYDROCHLORIDE Treats
1 indicationsTRIENTINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Wilson's Disease
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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.
TRIENTINE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsules is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. Trientine hydrochloride capsules and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.