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

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Summary

The FDA approved a supplemental application for OPSUMIT (macitentan) by Actelion Pharmaceuticals US, Inc., updating the product labeling via a supplemental NDA.

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Diseases / indications

• Pulmonary Arterial Hypertension

Drugs mentioned

• OPSUMIT (macitentan)

Snippet

SUPPL AP for OPSUMIT (MACITENTAN)