The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of an investigational single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH. The application is based on positive data from a Phase 3 study. PAH is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation that eventually leads to right heart failure.