FDA
approval
· 2025-11-05
FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
Summary
The FDA approved a supplemental application for Tracleer (bosentan) submitted by Actelion, resulting in an update to the product's labeling.
Upgrade for the full analysis, importance score, and drug timeline.
Diseases / indications
Drugs mentioned
Snippet
SUPPL AP for TRACLEER (BOSENTAN)