Actelion Tracleer "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Endothelin receptor antagonist Tracleer (bosentan) should be launched by the end of this year, pending discussions with FDA on liver toxicity risk management programs and labeling, Actelion projects. The pulmonary hypertension agent, which became "approvable" Sept. 17, is associated with liver toxicity, and the firm is planning to establish a registry to send liver monitoring reminders to physicians and patients. FDA's Cardiovascular and Renal Drugs Advisory Committee recommended approval of the agent Aug. 10