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Opsumit FDA Approval History

FDA Approved: Yes (First approved October 18, 2013)
Brand name: Opsumit
Generic name: macitentan
Dosage form: Tablets
Company: Actelion Pharmaceuticals US, Inc.
Treatment for: Pulmonary Arterial Hypertension

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

Development timeline for Opsumit

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

Further information

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