(contact us for more information on Tracleer)
Brand NameTracleer
Generic Namebosentan
Marketed byActelion Pharmaceuticals Ltd
NDA/BLA HolderActelion Pharmaceuticals US, Inc.
NDA/BLA NumberNDA 21-290
NDA/BLA Approval Date11/20/2001
Review ClassificationStandard, Orphan drug
REMS Approval Date3/25/2008
Class REMSNo
REMS Source Document
Boxed Warning?
Boxed Warning
Route of Administration
Mechanism of Action
Risks (MedGuide Language)
Approved Labeling
Medication Guide?
Medication Guide
Medication Guide Version
Communication Plan?
Communication Plan
Elements to Assure Safe Use?
Elements to Assure Safe Use
Implementation System?
Implementation System
Assessment Program
Assessment Program Timeline
Branded Program
Program Description
Link to Branded Program
Approval Letters


REMS Document: from FDA Approved REMS

Approval Letters: from FDA Medication Guide Website

Approved Labeling: from FDA Medication Guide Website

Medication Guide: from FDA Medication Guide Website

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