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FDA approval · 2026-03-03

FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

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Summary

FDA approved a supplemental application for TRACLEER (bosentan) submitted by Actelion Pharmaceuticals US, Inc., resulting in changes to the approved labeling.

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Diseases / indications

Drugs mentioned

  • TRACLEER (bosentan)

Snippet

SUPPL AP for TRACLEER (BOSENTAN)