DOFETILIDE
Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm.
Details
- Status
- Prescription
- First Approved
- 2016-06-06
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
DOFETILIDE Approval History
What DOFETILIDE Treats
11 FDA approvalsOriginally approved for its first indication in 2016 . Covers 11 distinct patient populations.
- Other (11)
Other
(11 approvals)- • Approved indication (Jun 2016)Label Letter
- • Approved indication (Mar 2018)
- • Approved indication (Apr 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Dec 2019)
- • Approved indication (Dec 2019)
- • Approved indication (Jan 2020)
- • Approved indication (Jun 2020)
- • Approved indication (Oct 2021)
- • Approved indication (Apr 2022)
- • Approved indication (Apr 2022)
DOFETILIDE Boxed Warning
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on dofetilide capsules should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. For detailed instructions regarding dose selection, see DOSAGE AND ADMINISTRATION ....
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on dofetilide capsules should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. For detailed instructions regarding dose selection, see DOSAGE AND ADMINISTRATION .
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01873950 results posted | 13-011D SCR-002 | Ph 1 | completed | Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects |
| NCT02308748 results posted | 14-022D SCR-003 | Ph 1 | completed | Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block |
| NCT02365532 | GS-US-372-1666 | Ph 1 | completed | Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults |
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.
DOFETILIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter ai...
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on dofetilide capsules should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. For detailed inst...
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DOFETILDE
Full clinical data, patents, trials, and competitive landscape for dofetilide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.