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Bosentan

Generic Name
Bosentan
Brand Names
Stayveer, Tracleer
Drug Type
Small Molecule
Chemical Formula
C27H29N5O6S
CAS Number
147536-97-8
Unique Ingredient Identifier
XUL93R30K2

Overview

Bosentan is a dual endothelin receptor antagonist marketed under the trade name Tracleer by Actelion Pharmaceuticals. Bosentan is used to treat pulmonary hypertension by blocking the action of endothelin molecules that would otherwise promote narrowing of the blood vessels and lead to high blood pressure.

Background

Bosentan is a dual endothelin receptor antagonist marketed under the trade name Tracleer by Actelion Pharmaceuticals. Bosentan is used to treat pulmonary hypertension by blocking the action of endothelin molecules that would otherwise promote narrowing of the blood vessels and lead to high blood pressure.

Indication

Used in the treatment of pulmonary arterial hypertension (PAH), to improve exercise ability and to decrease the rate of clinical worsening (in patients with WHO Class III or IV symptoms).

Associated Conditions

  • NYHA Functional Class II-IV Pulmonary arterial hypertension
  • Ocular Inflammation
  • Ocular bacterial infections

FDA Approved Products

bosentan
Manufacturer:Actavis Pharma, Inc.
Route:ORAL
Strength:125 mg in 1 1
Approved: 2023/10/31
NDC:0591-2512
Bosentan
Manufacturer:Zydus Pharmaceuticals USA Inc.
Route:ORAL
Strength:125 mg in 1 1
Approved: 2024/02/27
NDC:68382-447
Bosentan
Manufacturer:Amneal Pharmaceuticals LLC
Route:ORAL
Strength:62.5 mg in 1 1
Approved: 2019/06/18
NDC:65162-873
bosentan
Manufacturer:Actavis Pharma, Inc.
Route:ORAL
Strength:62.5 mg in 1 1
Approved: 2023/10/31
NDC:0591-2511
Bosentan
Manufacturer:Zydus Lifesciences Limited
Route:ORAL
Strength:125 mg in 1 1
Approved: 2023/09/20
NDC:70771-1018

Singapore Approved Products

TRACLEER TABLET 125 mg
Manufacturer:PATHEON INC
Form:TABLET, FILM COATED
Strength:125 mg
Online:Yes
Approved: 2004/05/06
Approval:SIN12543P
PROART FILM COATED TABLETS 62.5MG
Manufacturer:SUN PHARMACEUTICAL INDUSTRIES LIMITED
Form:TABLET, FILM COATED
Strength:62.50mg
Online:Yes
Approved: 2016/12/09
Approval:SIN15133P
PROART FILM COATED TABLETS 125MG
Manufacturer:SUN PHARMACEUTICAL INDUSTRIES LIMITED
Form:TABLET, FILM COATED
Strength:125.00mg
Online:Yes
Approved: 2016/12/09
Approval:SIN15132P

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