Opsumit FDA Approval History

FDA Approved: Yes (First approved October 18, 2013)
Brand name: Opsumit
Generic name: macitentan
Dosage form: Tablets
Company: Johnson & Johnson Innovative Medicine
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

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

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA