Actelion FDA Tuesday, September 5, 2017 0.00 Neutral

FDA Approves TRACLEER — Actelion Pharmaceuticals US, Inc.

# FDA Approves Actelion Pharmaceuticals' TRACLEER (bosentan) Oral Formulation Actelion Pharmaceuticals US, Inc. received FDA approval for TRACLEER (bosentan) oral formulation under NDA 209279, potentially expanding the company's market reach within the pulmonary arterial hypertension treatment landscape. The approval could strengthen Actelion's competitive position in the endothelin receptor antagonist segment, though market impact will depend on pricing, reimbursement, and the existing competitive dynamics with other PAH therapies.

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