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Warfarin

Generic Name
Warfarin
Brand Names
Coumadin, Jantoven
Drug Type
Small Molecule
Chemical Formula
C19H16O4
CAS Number
81-81-2
Unique Ingredient Identifier
5Q7ZVV76EI

Overview

Warfarin is an anticoagulant drug normally used to prevent blood clot formation as well as migration. Although originally marketed as a pesticide (d-Con, Rodex, among others), Warfarin has since become the most frequently prescribed oral anticoagulant in North America. Warfarin has several properties that should be noted when used medicinally, including its ability to cross the placental barrier during pregnancy which can result in fetal bleeding, spontaneous abortion, preterm birth, stillbirth, and neonatal death. Additional adverse effects such as necrosis, purple toe syndrome, osteoporosis, valve and artery calcification, and drug interactions have also been documented with warfarin use. Warfarin does not actually affect blood viscosity, rather, it inhibits vitamin-k dependent synthesis of biologically active forms of various clotting factors in addition to several regulatory factors.

Background

Warfarin is an anticoagulant drug normally used to prevent blood clot formation as well as migration. Although originally marketed as a pesticide (d-Con, Rodex, among others), Warfarin has since become the most frequently prescribed oral anticoagulant in North America. Warfarin has several properties that should be noted when used medicinally, including its ability to cross the placental barrier during pregnancy which can result in fetal bleeding, spontaneous abortion, preterm birth, stillbirth, and neonatal death. Additional adverse effects such as necrosis, purple toe syndrome, osteoporosis, valve and artery calcification, and drug interactions have also been documented with warfarin use. Warfarin does not actually affect blood viscosity, rather, it inhibits vitamin-k dependent synthesis of biologically active forms of various clotting factors in addition to several regulatory factors.

Indication

Indicated for: 1) Prophylaxis and treatment of venous thromboembolism and related pulmonary embolism. 2) Prophylaxis and treatment of thromboembolism associated with atrial fibrillation. 3) Prophylaxis and treatment of thromboembolism associated with cardiac valve replacement. 4) Use as adjunct therapy to reduce mortality, recurrent myocardial infarction, and thromboembolic events post myocardial infarction. Off-label uses include: 1) Secondary prevention of stroke and transient ischemic attacks in patients with rheumatic mitral valve disease but without atrial fibrillation.

Associated Conditions

  • Myocardial Infarction
  • Pulmonary Embolism
  • Stroke
  • Systemic Embolism
  • Thromboembolism
  • Transient Ischemic Attack
  • Venous Thrombosis (Disorder)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/08
Early Phase 1
Not yet recruiting
2025/04/09
Phase 1
Recruiting
2025/01/14
Phase 1
Completed
2024/12/18
Phase 4
Recruiting
2024/12/09
Phase 1
Completed
2024/11/13
Phase 1
Active, not recruiting
2024/10/23
Phase 4
Recruiting
2024/09/20
N/A
Completed
Abu Dhabi Health Services Company
2024/07/23
Phase 4
Recruiting
2024/06/10
Not Applicable
Active, not recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Aphena Pharma Solutions - Tennessee, LLC
43353-054
ORAL
10 mg in 1 1
4/25/2015
Cardinal Health 107, LLC
55154-4697
ORAL
5 mg in 1 1
6/29/2019
American Health Packaging
68084-027
ORAL
2.5 mg in 1 1
12/14/2023
Northwind Pharmaceuticals, LLC.
51655-629
ORAL
5 mg in 1 1
4/3/2023
Golden State Medical Supply, Inc.
51407-345
ORAL
4 mg in 1 1
6/7/2022
Proficient Rx LP
63187-750
ORAL
10 mg in 1 1
5/1/2020
Med-Health Pharma, LLC
51138-061
ORAL
7.5 mg in 1 1
2/9/2011
Zydus Lifesciences Limited
65841-053
ORAL
2 mg in 1 1
10/3/2023
Amneal Pharmaceuticals LLC
65162-767
ORAL
6 mg in 1 1
11/20/2022
Zydus Lifesciences Limited
65841-064
ORAL
2.5 mg in 1 1
10/3/2023

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
Apo-Warfarin 2mg Tablet
SIN13516P
TABLET
2 mg
8/12/2008
Apo-Warfarin 1mg Tablet
SIN13515P
TABLET
1 mg
8/12/2008
Apo-Warfarin 5mg Tablet
SIN13517P
TABLET
5 mg
8/12/2008
MAREVAN TABLET 3 mg (NEW ZEALAND)
SIN08019P
TABLET
3 mg
2/2/1995
MAREVAN TABLET 5 mg (NEW ZEALAND)
SIN08147P
TABLET
5 mg
5/5/1995
MAREVAN TABLET 1 mg (NEW ZEALAND)
SIN08146P
TABLET
1 mg
5/5/1995

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Warfarin Sodium Tablets
国药准字H20054247
化学药品
片剂
11/20/2020
Warfarin Sodium Tablets
国药准字HJ20171095
化学药品
片剂
10/25/2022
Warfarin Sodium Tablets
国药准字H31022141
化学药品
片剂(糖衣、薄膜衣)
2/26/2020
Warfarin Sodium Tablets
国药准字H20233268
化学药品
片剂
3/15/2023
Warfarin Sodium Tablets
国药准字H20084641
化学药品
片剂(薄膜衣)
9/13/2021
Warfarin Sodium Tablets
国药准字H20103600
化学药品
片剂
11/20/2020
Warfarin Sodium Tablets
国药准字H19993692
化学药品
片剂
6/12/2020
Warfarin Sodium Tablets
国药准字H31022123
化学药品
片剂
2/10/2020
Warfarin Sodium Tablets
国药准字H31020993
化学药品
片剂
11/28/2019
Warfarin Sodium Tablets
国药准字H37021314
化学药品
片剂
9/10/2019

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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