Flecainide

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

Title	Posted	Study ID	Phase	Status	Sponsor
Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy	2025/04/29	NCT06949748	N/A	Recruiting	University of Athens
N-of-1 in ATS and MEPPC	2024/01/16	NCT06205550	Phase 2	Not yet recruiting	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery	2023/11/21	NCT06142604	Phase 4	Withdrawn	Population Health Research Institute
Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse	2022/11/30	NCT05631730	Phase 3	Recruiting	Oslo University Hospital
Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia	2022/09/22	NCT05549752	Phase 3	Recruiting	Hippocration General Hospital
Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia	2022/01/28	NCT05213104	Phase 3	Active, not recruiting	Assistance Publique - Hôpitaux de Paris
Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation	2021/09/09	NCT05039359	Phase 3	Terminated	InCarda Therapeutics, Inc.
Beta Blockers Plus Intravenous Flecainide for Paroxysmal Atrial Fibrillation: a Real-world Chios Registry (BETAFLEC-CHIOS)	2021/08/05	NCT04991896	N/A	Completed	AHEPA University Hospital
Shortening Duration of Antiarrhythmic Medication for SVT in Infants	2021/04/08	NCT04837261	N/A	UNKNOWN	Tampere University Hospital
Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment	2019/02/19	NCT03845010	Not Applicable	Completed	Maatschap Cardiologie Zwolle

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Flecainide Acetate	Chartwell RX, LLC	62135-660	ORAL	50 mg in 1 1	6/23/2023
Flecainide Acetate	Aurobindo Pharma Limited	65862-623	ORAL	150 mg in 1 1	1/9/2024
Flecainide Acetate	Bryant Ranch Prepack	63629-7982	ORAL	100 mg in 1 1	11/11/2020
Flecainide Acetate	Rising Pharma Holdings, Inc.	57237-064	ORAL	100 mg in 1 1	1/9/2024
Flecainide Acetate	PD-Rx Pharmaceuticals, Inc.	72789-385	ORAL	50 mg in 1 1	2/27/2024
Flecainide Acetate	Rising Pharma Holdings, Inc.	57237-065	ORAL	150 mg in 1 1	1/9/2024
Flecainide Acetate	Physicians Total Care, Inc.	54868-5074	ORAL	50 mg in 1 1	12/10/2010
Flecainide Acetate	Ranbaxy Pharmaceuticals Inc.	63304-796	ORAL	150 mg in 1 1	1/19/2012
Flecainide Acetate	Aurobindo Pharma Limited	65862-622	ORAL	100 mg in 1 1	1/9/2024
Flecainide Acetate	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	Aizant Drug Research Solutions Pvt. Ltd.	SIN16823P	TABLET	100mg	7/18/2023
TAMBOCOR TABLET 100 mg	Unique Pharmaceutical Laboratories, (A Division of J.B. Chemicals & Pharmaceuticals Limited)	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	iNOVA Pharmaceuticals (Hong Kong) Limited	N/A	N/A	3/20/1985
TAMBOCOR CR CAP 200MG	N/A	iNOVA Pharmaceuticals (Hong Kong) Limited	N/A	N/A	12/1/2011
TAMBOCOR CR CAP 100MG	N/A	iNOVA Pharmaceuticals (Hong Kong) Limited	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	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	12/9/1999
Flecainide BNM flecainide acetate 100 mg tablet blister pack	232475	Boucher & Muir Pty Ltd	Medicine	A	11/20/2015
FLECAINIDE MLabs flecainide acetate 100 mg tablet blister pack	289975	Micro Labs Pty Ltd	Medicine	A	6/19/2018
Flec-EM flecainide acetate 50 mg tablet blister pack	311991	Emcure Pharmaceuticals Pty Ltd	Medicine	A	5/27/2020
Tambocor CR 100 mg	139564	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	5/28/2007
FLECAINIDE ACETATE 100mg (AF3) tablet-bulk.	112681	Alphapharm Pty Ltd	Medicine	A	10/20/2004
FLECACOR flecainide acetate 50mg tablet blister pack	72002	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	12/7/1999
Tambocor CR 200 mg	139565	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	5/28/2007
FLECAIN flecainide acetate 50mg tablet blister pack	289982	Micro Labs Pty Ltd	Medicine	A	6/19/2018
FLECAINIDE MLabs flecainide acetate 50 mg tablet blister pack	289976	Micro Labs Pty Ltd	Medicine	A	6/19/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
FLECAINIDE	sanis health inc	02534819	Tablet - Oral	100 MG	10/24/2023
AURO-FLECAINIDE	auro pharma inc	02459965	Tablet - Oral	100 MG	2/27/2017
JAMP FLECAINIDE	Jamp Pharma Corporation	02493713	Tablet - Oral	100 MG	11/13/2020
AG-FLECAINIDE	angita pharma inc.	02516071	Tablet - Oral	100 MG	6/8/2023
APO-FLECAINIDE	Apotex Inc	02275546	Tablet - Oral	100 MG	5/8/2006
TAMBOCOR	bausch health, canada inc.	01966197	Tablet - Oral	50 MG	12/31/1988
NRA-FLECAINIDE	nora pharma inc	02530074	Tablet - Oral	100 MG	4/13/2023
TAMBOCOR	bausch health, canada inc.	01966200	Tablet - Oral	100 MG	12/31/1966
AURO-FLECAINIDE	auro pharma inc	02459957	Tablet - Oral	50 MG	2/27/2017
JAMP FLECAINIDE	Jamp Pharma Corporation	02493705	Tablet - Oral	50 MG	10/27/2020

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.

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Overview

Indication

Associated Conditions

Clinical Trials

FDA Drug Approvals

EMA Drug Approvals

HSA Drug Approvals

NMPA Drug Approvals

PPB Drug Approvals

TGA Drug Approvals

Health Canada Drug Approvals

CIMA AEMPS Drug Approvals

Philippines FDA Drug Approvals

Saudi SFDA Drug Approvals

Malaysia NPRA Drug Approvals

UK EMC Drug Information

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