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# Janssen NDA for Pulmonary Hypertension Drug
- URL: https://www.fdaweb.com/janssen-nda-for-pulmonary-hypertension-drug/
- Published: 2023-05-30T12:00:00.000Z
- Updated: 2026-09-14T18:35:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154563

Janssen has submitted an NDA to FDA for an investigational single-tablet combination of macitentan (Janssen’s Opsumit) 10 mg and tadalafil (Lilly’s Cialis and others) 40 mg for the long-term treatment of pulmonary arterial hypertension in some specified adult patients. A company [statement](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-england-life-care-inc-dba-advanced-compounding-solutions-659161-05162023?ref=fdaweb.com) says the NDA is based on positive data from the Phase 3 A DUE study which met its primary endpoint and demonstrated that the combination drug significantly improved hemodynamics versus macitentan and tadalafil monotherapies in the patient population.