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FDA approval · 2025-11-05

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

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Summary

The FDA approved a supplemental application for Tracleer (bosentan) submitted by Actelion, resulting in an update to the product's labeling.

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Diseases / indications

Drugs mentioned

  • TRACLEER (bosentan)

Snippet

SUPPL AP for TRACLEER (BOSENTAN)