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.
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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/09/26 | Phase 2 | Completed | |||
2018/07/16 | Phase 4 | UNKNOWN | |||
2018/05/29 | Phase 2 | Completed | |||
2017/05/22 | Phase 2 | Withdrawn | |||
2016/12/29 | Phase 4 | Completed | David Filgueiras-Rama | ||
2015/12/08 | Phase 3 | Completed | Edgar Jaeggi | ||
2015/01/27 | Phase 4 | Recruiting | |||
2014/11/26 | N/A | Completed | |||
2014/11/19 | Not Applicable | UNKNOWN | |||
2014/04/10 | Not Applicable | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| PD-Rx Pharmaceuticals, Inc. | 72789-384 | ORAL | 150 mg in 1 1 | 3/5/2024 | |
| ANI Pharmaceuticals, Inc. | 62559-382 | ORAL | 150 mg in 1 1 | 8/16/2017 | |
| Bayshore Pharmaceuticals LLC | 76385-145 | ORAL | 50 mg in 1 1 | 1/11/2024 | |
| Amneal Pharmaceuticals of New York LLC | 53746-641 | ORAL | 50 mg in 1 1 | 12/31/2023 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-383 | ORAL | 100 mg in 1 1 | 2/28/2024 | |
| Bryant Ranch Prepack | 63629-9184 | ORAL | 50 mg in 1 1 | 8/16/2017 | |
| A-S Medication Solutions | 50090-2233 | ORAL | 100 mg in 1 1 | 11/12/2020 | |
| Bryant Ranch Prepack | 63629-1981 | ORAL | 150 mg in 1 1 | 8/16/2017 | |
| Amneal Pharmaceuticals LLC | 65162-641 | ORAL | 50 mg in 1 1 | 12/19/2023 | |
| A-S Medication Solutions | 50090-5267 | ORAL | 100 mg in 1 1 | 11/11/2020 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BPA-FLECAINIDE 50 flecainide acetate 50 mg tablet blister pack | 317340 | Medicine | A | 4/15/2020 | |
| Flecainide acetate tablets 100mg (AF2) bulk. | 101235 | Medicine | A | 5/4/2004 | |
| Flecainide Sandoz flecainide acetate 100 mg tablet blister pack | 232474 | Medicine | A | 11/20/2015 | |
| BPA-FLECAINIDE 100 flecainide acetate 100 mg tablet blister pack | 317341 | Medicine | A | 4/15/2020 | |
| TAMBOCOR flecainide acetate 100mg tablet blister pack | 41002 | Medicine | A | 8/27/1992 | |
| Flecainide BNM flecainide acetate 50 mg tablet blister pack | 232476 | Medicine | A | 11/20/2015 | |
| FLECAR flecainide acetate 50 mg tablet blister pack | 289978 | Medicine | A | 6/19/2018 | |
| TAMBOCOR flecainide acetate 50mg tablet blister pack | 41001 | Medicine | A | 8/27/1992 | |
| APO-FLECAINIDE flecainide acetate 50mg tablet blister pack | 289980 | Medicine | A | 6/19/2018 | |
| Flec-EM flecainide acetate 100 mg tablet blister pack | 311992 | Medicine | A | 5/27/2020 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| MAR-FLECAINIDE | marcan pharmaceuticals inc | 02476177 | Tablet - Oral | 50 MG | 1/19/2021 |
| MAR-FLECAINIDE | marcan pharmaceuticals inc | 02476185 | Tablet - Oral | 100 MG | 1/19/2021 |
| FLECAINIDE | sanis health inc | 02534800 | Tablet - Oral | 50 MG | 10/24/2023 |
| NRA-FLECAINIDE | nora pharma inc | 02530066 | Tablet - Oral | 50 MG | 4/13/2023 |
| AG-FLECAINIDE | angita pharma inc. | 02516063 | Tablet - Oral | 50 MG | 6/8/2023 |
| APO-FLECAINIDE | 02275538 | Tablet - Oral | 50 MG | 5/8/2006 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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