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| | | ![]() Tracleer (Bosentan), Oral Treatment For Pulmonary Arterial Hypertension, Available In US ALLSCHWIL, SWITZERLAND -- December 5, 2001 -- Actelion Ltd. announced the commercial availability in the United States of Tracleer™ (bosentan), an orally active endothelin receptor antagonist for the treatment of pulmonary arterial hypertension (PAH). Tracleer, approved by the U.S. Food and Drug Administration on November 20, 2001, is indicated to improve exercise ability and decrease the rate of clinical worsening in PAH patients with significant limitation of physical activity (WHO Class III and IV). PAH is a chronic, life-threatening disorder that can severely compromise the function of the lungs and heart. Tracleer is available in bottles of 60 tablets in strengths of 62.5 mg and 125 mg through a limited group of four specialty pharmacy distributors: Caremark Inc., Gentiva Health Services, Nova Factor Inc. and Procare Pharmacy Inc. Approximately 11 percent of patients receiving Tracleer experienced abnormal, but reversible liver enzyme elevations. It is therefore important that patients undergo monthly liver monitoring. Due to the risk of birth defects, women who are pregnant, or may become pregnant, cannot take Tracleer. Monthly pregnancy tests are required for woman of child-bearing potential.
SOURCE Actelion Ltd.
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