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Actelion submits a NDA for macitentan for the treatment of patients with pulmonary arterial hypertension
23-10-2012
Actelion announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for macitentan (Opsumit®) for the treatment of patients with pulmonary arterial hypertension.Macitentan, a novel oral dual endothelin receptor antagonist, was ...
Actelion receives FDA complete response letter for Zavesca (miglustat) for the treatment of Niemann-Pick type C disease
10-03-2010
Actelion Ltd announced that the company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for Zavesca® (miglustat) for the treatment of progressive neurological manifestations in adult and pediatric ...
Zavesca receives positive vote from FDA for the treatment of Niemann-Pick type C disease
15-01-2010
Actelion Ltd announced that United States (US) Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted (10 yes to 3 no) in its final vote in question that the benefit/risk profile of Zavesca® (miglustat) supports its approval for the treatment of ...
US Food and Drug Administration grants priority review for Actelion's miglustat in Niemann-Pick type C disease
19-11-2009
Actelion Ltd announced that a supplemental new drug application (sNDA) for an extension of indication for Zavesca® (miglustat) for the treatment of progressive neurological manifestations in adult and pediatric patients with Niemann-Pick type C disease (NP-C) has been accepted by the U.S. ...
Tracleer receives label extension in the US
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 ...
Actelion's PGI2 receptor agonist demonstrates efficacy in pulmonary arterial hypertension patients
Morbidity-Mortality Phase III study to be initiated before year-end
20-07-2009
Actelion Ltd announced that positive data have been obtained in a Phase IIa study with its first-in-class orally active non-prostanoid PGI2 receptor agonist in pulmonary arterial hypertension (PAH) patients. In the 43 patient placebo-controlled double-blind study to assess efficacy, safety ...
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