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 | Active, not recruiting | |||
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. | |||||
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