Overview
Dofetilide is a class III antiarrhythmic agent that is approved by the Food and Drug Administration (FDA) for the maintenance of sinus rhythm in individuals prone to the formation of atrial fibrillation and flutter, and for the chemical cardioversion to sinus rhythm from atrial fibrillation and flutter.
Indication
用于心房扑动、心房颤动、室上性心动过速。
Associated Conditions
- Normal Sinus Rhythm
- Symptomatic Atrial flutter
- Symptomatic, recurrent Atrial Fibrillation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/06/18 | Phase 1 | Terminated | |||
2019/10/16 | N/A | Completed | Samir Saba | ||
2017/03/03 | Phase 1 | Completed | Food and Drug Administration (FDA) | ||
2015/05/12 | N/A | UNKNOWN | |||
2015/02/19 | Phase 1 | Completed | |||
2014/12/04 | Phase 1 | Completed | Food and Drug Administration (FDA) | ||
2013/06/10 | Phase 1 | Completed | Food and Drug Administration (FDA) | ||
2006/12/06 | Not Applicable | Completed | |||
2006/10/25 | Phase 3 | Suspended |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novadoz Pharmaceuticals LLC | 72205-039 | ORAL | 0.125 mg in 1 1 | 7/1/2020 | |
| VGYAAN Pharmaceuticals LLC | 72664-230 | ORAL | 0.25 mg in 1 1 | 10/4/2023 | |
| Major Pharmaceuticals | 0904-6681 | ORAL | 0.125 mg in 1 1 | 12/2/2020 | |
| Sun Pharmaceutical Industries, Inc. | 47335-061 | ORAL | 0.125 mg in 1 1 | 11/1/2023 | |
| Novadoz Pharmaceuticals LLC | 72205-041 | ORAL | 0.500 mg in 1 1 | 7/1/2020 | |
| MSN LABORATORIES PRIVATE LIMITED | 69539-130 | ORAL | 0.125 mg in 1 1 | 3/19/2019 | |
| MSN LABORATORIES PRIVATE LIMITED | 69539-132 | ORAL | 0.500 mg in 1 1 | 3/19/2019 | |
| Avera McKennan Hospital | 69189-5820 | ORAL | 0.5 mg in 1 1 | 3/24/2017 | |
| Liberty Bioscience LLC | 71410-300 | ORAL | 0.125 mg in 1 1 | 10/17/2018 | |
| Mayne Pharma Inc. | 51862-025 | ORAL | 0.25 mg in 1 1 | 12/9/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.