Actelion Tracleer gets approval recommendation
This article was originally published in Pharmaceutical Approvals Monthly
Actelion's oral endothelin receptor antagonist Tracleer is recommended for approval Aug. 10 by FDA's Cardiovascular and Renal Drugs Advisory Committee. The bosentan NDA for treatment of pulmonary arterial hypertension is based on two Phase III studies showing a 44-meter improvement in walking distance. The company is planning to establish a patient registry to send monthly liver monitoring reminders to patients
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