Overview
Flecainide is a Class I anti-arrhythmic agent like encainide and propafenone. Flecainide’s development began in 1966 and was first synthesized in 1972 as an attempt to generate new anesthetics. It is used to prevent supraventricular and ventricular arrhythmias, as well as paroxysmal atrial fibrillation and flutter. Flecainide was granted FDA approval on 31 October 1985.
Background
Flecainide is a Class I anti-arrhythmic agent like encainide and propafenone. Flecainide’s development began in 1966 and was first synthesized in 1972 as an attempt to generate new anesthetics. It is used to prevent supraventricular and ventricular arrhythmias, as well as paroxysmal atrial fibrillation and flutter. Flecainide was granted FDA approval on 31 October 1985.
Indication
In New Zealand and America, flecainide is indicated to prevent supraventricular arrhythmias and ventricular arrhythmias. In the United States, it is also indicated to prevent paroxysmal atrial fibrillation and flutter.
Associated Conditions
- Atrial Fibrillation
- Ventricular Tachycardia (VT)
- Severe Atrioventricular nodal reentrant tachycardia
- Severe Paroxysmal atrial fibrillation
- Severe Paroxysmal supraventricular tachycardia
- Severe Supraventricular Tachycardias
- Severe Sustained ventricular tachycardia
- Severe ventricular arrhythmias
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/29 | N/A | Recruiting | University of Athens | ||
2024/01/16 | Phase 2 | Not yet recruiting | |||
2023/11/21 | Phase 4 | Withdrawn | |||
2022/11/30 | Phase 3 | Recruiting | Oslo University Hospital | ||
2022/09/22 | Phase 3 | Recruiting | Hippocration General Hospital | ||
2022/01/28 | Phase 3 | Active, not recruiting | |||
2021/09/09 | Phase 3 | Terminated | |||
2021/08/05 | N/A | Completed | |||
2021/04/08 | N/A | UNKNOWN | |||
2019/02/19 | Not Applicable | Completed | Maatschap Cardiologie Zwolle |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Chartwell RX, LLC | 62135-660 | ORAL | 50 mg in 1 1 | 6/23/2023 | |
| Aurobindo Pharma Limited | 65862-623 | ORAL | 150 mg in 1 1 | 1/9/2024 | |
| Bryant Ranch Prepack | 63629-7982 | ORAL | 100 mg in 1 1 | 11/11/2020 | |
| Rising Pharma Holdings, Inc. | 57237-064 | ORAL | 100 mg in 1 1 | 1/9/2024 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-385 | ORAL | 50 mg in 1 1 | 2/27/2024 | |
| Rising Pharma Holdings, Inc. | 57237-065 | ORAL | 150 mg in 1 1 | 1/9/2024 | |
| Physicians Total Care, Inc. | 54868-5074 | ORAL | 50 mg in 1 1 | 12/10/2010 | |
| Ranbaxy Pharmaceuticals Inc. | 63304-796 | ORAL | 150 mg in 1 1 | 1/19/2012 | |
| Aurobindo Pharma Limited | 65862-622 | ORAL | 100 mg in 1 1 | 1/9/2024 | |
| A-S Medication Solutions | 50090-2968 | ORAL | 100 mg in 1 1 | 8/16/2017 |
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 |
|---|---|---|---|---|---|
| JAMP FLECAINIDE ACETATE TABLETS USP 100 MG | SIN16823P | TABLET | 100mg | 7/18/2023 | |
| TAMBOCOR TABLET 100 mg | SIN01726P | TABLET | 100 mg | 6/9/1988 |
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 |
|---|---|---|---|---|---|
| TAMBOCOR TAB 100MG | N/A | N/A | N/A | 3/20/1985 | |
| TAMBOCOR CR CAP 200MG | N/A | N/A | N/A | 12/1/2011 | |
| TAMBOCOR CR CAP 100MG | N/A | N/A | N/A | 12/1/2011 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FLECACOR flecainide acetate 100mg tablet blister pack | 72003 | Medicine | A | 12/9/1999 | |
| Flecainide BNM flecainide acetate 100 mg tablet blister pack | 232475 | Medicine | A | 11/20/2015 | |
| FLECAINIDE MLabs flecainide acetate 100 mg tablet blister pack | 289975 | Medicine | A | 6/19/2018 | |
| Flec-EM flecainide acetate 50 mg tablet blister pack | 311991 | Medicine | A | 5/27/2020 | |
| Tambocor CR 100 mg | 139564 | Medicine | A | 5/28/2007 | |
| FLECAINIDE ACETATE 100mg (AF3) tablet-bulk. | 112681 | Medicine | A | 10/20/2004 | |
| FLECACOR flecainide acetate 50mg tablet blister pack | 72002 | Medicine | A | 12/7/1999 | |
| Tambocor CR 200 mg | 139565 | Medicine | A | 5/28/2007 | |
| FLECAIN flecainide acetate 50mg tablet blister pack | 289982 | Medicine | A | 6/19/2018 | |
| FLECAINIDE MLabs flecainide acetate 50 mg tablet blister pack | 289976 | Medicine | A | 6/19/2018 |