On 22 October, Actelion announced that the company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for macitentan (Opsumit®) for the treatment of patients with pulmonary arterial hypertension.
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“I am very pleased with the rapid progress the company has made in turning the outstanding clinical data into this submission, an important milestone for macitentan and indeed for Actelion. This brings us one step closer to our goal of delivering a new treatment option for patients with pulmonary arterial hypertension.”
For more information on the FDA's drug review process visit the FDA website at the following links:
