MedPath

Leflunomide

Generic Name
Leflunomide
Brand Names
Arava, Leflunomide medac, Leflunomide Zentiva (previously Leflunomide Winthrop), Leflunomide ratiopharm
Drug Type
Small Molecule
Chemical Formula
C12H9F3N2O2
CAS Number
75706-12-6
Unique Ingredient Identifier
G162GK9U4W

Overview

Leflunomide is a pyrimidine synthesis inhibitor belonging to the DMARD (disease-modifying antirheumatic drug) class of drugs, which are chemically and pharmacologically very heterogeneous. Leflunomide was approved by FDA and in many other countries (e.g., Canada, Europe) in 1999.

Background

Leflunomide is a pyrimidine synthesis inhibitor belonging to the DMARD (disease-modifying antirheumatic drug) class of drugs, which are chemically and pharmacologically very heterogeneous. Leflunomide was approved by FDA and in many other countries (e.g., Canada, Europe) in 1999.

Indication

For the management of the signs and symptoms of active rheumatoid arthritis (RA) to improve physical function and to slow the progression of structural damage associated with the disease. Has also been used for the prevention of acute and chronic rejection in recipients of solid organ trasnplants and is designated by the FDA as an orphan drug for this use.

Associated Conditions

  • Juvenile Idiopathic Arthritis (JIA)
  • Rheumatoid Arthritis

FDA Approved Products

Leflunomide
Manufacturer:Chartwell RX, LLC
Route:ORAL
Strength:20 mg in 1 1
Approved: 2023/10/31
NDC:62135-794
Leflunomide
Manufacturer:Aurobindo Pharma Limited
Route:ORAL
Strength:10 mg in 1 1
Approved: 2021/04/30
NDC:59651-348
LEFLUNOMIDE
Manufacturer:Apotex Corp.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/12/14
NDC:60505-2502
Leflunomide
Manufacturer:KVK-Tech, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2019/06/14
NDC:10702-277
Leflunomide
Manufacturer:Fosun Pharma USA Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2024/01/08
NDC:72266-132

Singapore Approved Products

ARAVA TABLET 20 mg
Manufacturer:Opella Healthcare International SAS
Form:TABLET, FILM COATED
Strength:20 mg
Online:Yes
Approved: 2000/10/14
Approval:SIN11400P
LEFLUNOMIDE MEVON FILM-COATED TABLETS 20 MG
Manufacturer:Pharmathen S.A.
Form:TABLET, FILM COATED
Strength:20.00 MG
Online:Yes
Approved: 2017/05/31
Approval:SIN15252P
ARAVA TABLET 100 mg
Manufacturer:Opella Healthcare International SAS
Form:TABLET, FILM COATED
Strength:100 mg
Online:Yes
Approved: 2000/10/14
Approval:SIN11401P
BAGEDA FILM-COATED TABLET 20MG
Manufacturer:WORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş.
Form:TABLET, FILM COATED
Strength:20.000mg
Online:Yes
Approved: 2024/10/08
Approval:SIN17108P

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