10-08-2009

Actelion Ltd announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for Tracleer® (bosentan) to treat patients with mildly symptomatic WHO Functional Class II (FC II) pulmonary arterial hypertension (PAH). The U.S. FDA ...

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The first and only licensed pulmonary arterial hypertension therapy for children

07-07-2009

Actelion Ltd announced that the pediatric dispersible formulation of Tracleer® (bosentan) for the treatment of pulmonary arterial hypertension (PAH) in children has been approved in the European Union. This approval makes Tracleer® the only PAH therapy with an approved pediatric formulation ...

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28-04-2009

Actelion Ltd announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), issued a positive opinion for the pediatric formulation of bosentan (Tracleer®) for the treatment of pulmonary arterial hypertension ...

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06-03-2007

Actelion Ltd announced the initial results from the double-blind, placebo-controlled, multicenter study BENEFiT (Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension). The study met its primary objective, as treatment with bosentan (Tracleer®) was associated ...

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06-09-2005

Actelion Ltd announced that two abstracts presented at the European Society of Cardiology (ESC) conference confirm the long-term safety profile of Tracleer® (bosentan) in treating pulmonary arterial hypertension (PAH). Both abstracts comprise data from TRAX PMSTM, which was set up in the EU ...

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