FDA
approval
· 2019-02-01
FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
Summary
FDA approved a supplemental application for OPSUMIT (macitentan) from Actelion Pharmaceuticals US, Inc., resulting in an update to the labeling.
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Diseases / indications
Drugs mentioned
Snippet
SUPPL AP for OPSUMIT (MACITENTAN)