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CORDARONE

NDA

AMIODARONE HYDROCHLORIDE | N020377 | WYETH PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

4 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Gensia Sicor Pharmaceuticals FDA-2002-P-0444 · 6 docket documents Gensia Sicor Pharmaceuticals filed this suitability petition under Section 505(j)(2)(c) and 21 CFR 314.93 requesting permission to submit an ANDA for Amiodarone Hydrochloride Injection 450 mg/9 mL in a single-use vial. The petitioner seeks to change the strength from the reference listed drug Cordar	Other	2023-03-30	Granted	Gensia Sicor Pharmaceuticals
Citizen Petition from Bioniche Pharma Group Limited FDA-2002-P-0397 · 5 docket documents Bioniche Pharma (Canada) Ltd. filed a supplemental ANDA suitability petition under 21 CFR 314.93 requesting permission to file a supplemental ANDA for Amiodarone Hydrochloride Injection, 50 mg/mL in a 9 mL vial (450 mg total content) based on approved ANDA 76-217, differing from the reference listed	Other	2023-03-30	Granted	Bioniche Pharma Group Limited
Background Material re Suitability Citizen Petition from Gensia Sicor Pharmac... FDA-2000-P-1558 · 5 docket documents Gensia Sicor Pharmaceuticals, Inc. filed an ANDA suitability petition requesting FDA approval for Camiodarone Hydrochloride Injection in a 900 mg/18 mL single-use vial strength. The petitioner argued that this new package size, designed to simplify preparation of the 1.8 mg/mL infusion concentration	Suitability	2023-03-30	Granted	Gensia Sicor Pharmaceuticals, Inc.
Citizen Petition from Lachman Consultant Services, Inc. FDA-2002-P-0440 · 5 docket documents Lachman Consultant Services, Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine that an Abbreviated New Drug Application may be submitted for Amiodarone Hydrochloride Injection in strengths of 300 mg/6 mL and 450 m	Other	2023-03-30	Granted	Lachman Consultant Services, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

85 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 43 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery NCT02750319	Phase 3	Active	Memorial Sloan Kettering Cancer Center	184	2016-04 → 2027-04
Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery NCT01422148	Phase 2	Not Yet Recruiting	Baystate Medical Center	60	2025-07 → 2028-01-24
Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment NCT03868150	Phase 4	Recruiting	Stanford University	600	2017-03-01 → 2050-12-31
Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation NCT00587483	N/A	Completed	Mayo Clinic	342	2007-11 → 2010-01
Prevention of Atrial Fibrillation Following Esophagectomy NCT00420017	Phase 4	Completed	Indiana University	80	2005-09 → 2008-11
Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease NCT02924285	Phase 3	Completed	University of Leipzig	80	2017-11-01 → 2021-03-04
Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)NCT00000609	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1997-05 → 2005-04
Withdrawal Versus Continuation of Amiodarone in Successfully Treated Patients With Persistent Atrial Fibrillation NCT00845780	Phase 4	Completed	University Medical Center Groningen	37	2000-08 → 2009-06
A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation NCT00668759	Phase 3	Completed	Advanz Pharma	254	2008-04 → 2009-11
Reduction of Atrial Fibrillation Study in Patients Undergoing Coronary Artery Bypass Grafting. (RASCABG 1 Study)NCT00287209	Phase 4	Completed	University of Aarhus	250	2004-01 → 2005-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain7 active DMFs5 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

PMC ISOCHEMAMIODARONE HYDROCHLORIDE

DMF 76171988

ALIVUS LIFE SCIENCES LTDAMIODARONE HYDROCHLORIDE USP

DMF 167872003

PIRAMAL PHARMA LTDAMIODARONE HYDROCHLORIDE

DMF 216942008

CTX LIFE SCIENCES PVT LTDAMIODARONE HYDROCHLORIDE USP

DMF 258922012

UNICHEM LABORATORIES LTDAMIODARONE HYDROCHLORIDE USP

DMF 336882019

HAINAN POLY PHARM CO LTDAMIODARONE HYDROCHLORIDE USP

DMF 361632021

EMCURE PHARMACEUTICALS LTDAMIODARONE HYDROCHLORIDE USP

DMF 381602023

SANOFI SYNTHELABO INCInactiveAMIODARONE HYDROCHLORIDE

DMF 49551983

LABORATOIRE CHOAYInactiveAMIODARONE HYDROCHLORIDE INJECTION

DMF 65291986

SHANGHAI SHENLONG PHARMACEUTICAL CO LTDInactiveAMIODARONE HYDROCHLORIDE

DMF 141711999

AUROBINDO PHARMA LTDInactiveAMIODARONE HYDROCHLORIDE

DMF 172172004

ZHEJIANG SANMEN HENGKANG PHARMACEUTICAL CO LTDInactiveAMIODARONE HYDROCHLORIDE

DMF 245182010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Sep 18, 2006	SUPPL -20	View Letter (PDF)
Sep 22, 2005	SUPPL -18	View Letter (PDF)
Nov 8, 2004	SUPPL -7	View Letter (PDF)
Nov 8, 2004	SUPPL -8	View Letter (PDF)
Nov 8, 2004	SUPPL -15	View Letter (PDF)
Nov 8, 2004	SUPPL -17	View Letter (PDF)
Sep 3, 2004	SUPPL -16	View Letter (PDF)
May 30, 2003	SUPPL -10	View Letter (PDF)
May 30, 2003	SUPPL -12	View Letter (PDF)
May 30, 2003	SUPPL -13	View Letter (PDF)
May 30, 2003	SUPPL -14	View Letter (PDF)
Jul 11, 2001	SUPPL -5	View Letter (PDF)
Jul 11, 2001	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 3, 1995

No patent or exclusivity listings for this strength.