Tracleer (bosentan) receives EU approval for treating PAH in children
Wednesday July 8, 2009
On July 6, 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. Actelion stated that this approval makes Tracleer the only PAH therapy with an approved formulation for treating children from two years of age. In the Actelion press release, Isaac Kobrin, M.D., Head of Clinical Development at Actelion stated, "Having the approval of Tracleer, with an accurate dosing in a child-friendly form, is an important advancement in the treatment of PAH in children. After receiving approval in the EU, we will continue our regulatory filings in other countries to ensure that children can benefit from this pediatric formulation of Tracleer on a worldwide basis."

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