Posted by Michael Wonder on 30 May 2023
Janssen submits new drug application to US FDA seeking approval of investigational single tablet combination therapy of macitentan and tadalafil for treatment of patients with pulmonary arterial hypertension
30 May 2023 - This is the first and only single tablet combination therapy application to be submitted for review in the US for this rare, progressive disease.
Janssen announced today the submission of a new drug application to the US FDA seeking approval of an investigational single tablet combination therapy of macitentan 10 mg and tadalafil 40 mg for the long-term treatment of pulmonary arterial hypertension (World Health Organization Group 1) in adult patients with WHO functional class II-III.
