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Opsumit Approval History

  • FDA approved: Yes (First approved October 18th, 2013)
  • Brand name: Opsumit
  • Generic name: macitentan
  • Company: Actelion Pharmaceuticals Ltd.
  • Treatment for: Pulmonary Hypertension

Opsumit (macitentan) is a dual endothelin receptor antagonist for the treatment of patients with pulmonary arterial hypertension.

FDA Approval History for Opsumit

DateArticle
Oct 18, 2013Approval FDA Approves Opsumit to Treat Pulmonary Arterial Hypertension
Dec 14, 2012Actelion Announces acceptance of the New Drug Application for macitentan by the US Food and Drug Administration
Oct 22, 2012Actelion submits a New Drug Application to the FDA for macitentan (Opsumit) for the treatment of patients with pulmonary arterial hypertension

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