TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

DOFETILIDE

DOFETILIDE
Approved 2016-06-06
Jump to: Indications Approvals Trials Competitors Safety Patents
11
Indications
--
Phase 3 Trials
9
Years on Market

Details

Status
Discontinued
First Approved
2016-06-06
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Teva PRINSTON INC GRANULES BIONPHARMA Dr. Reddy's SIGMAPHARM LABS LLC ACCORD HLTHCARE STRIDES PHARMA INTL RK PHARMA MSN Sun Pharma INGENUS PHARMS LLC
Active Ingredient: DOFETILIDE

DOFETILIDE Approval History

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What DOFETILIDE Treats

11 FDA approvals

Originally approved for its first indication in 2016 . Covers 11 distinct patient populations.

  • Other (11)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

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Data Sources

FDA Approval: ANDA210018 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.