FDA approves Johnson & Johnson`s combo pill Opsynvi for PAH
FDA Approves OPSYNVI® (macitentan and tadalafil) for Patients with PAH
Zydus` Generic Finasteride & Tadalafil Receives Approval in the U.S.
Today The World Issues Voluntary Nationwide Recall of All Lots of Sustain and Schwinnng brand Dietary Supplement Capsules Due to the Presence of Undeclared Tadalafil and Nortadalafil
This is the first and only single tablet combination therapy to be submitted for review in Europe for this rare, progressive disease If approved, Janssen™s comprehensive PAH portfolio has the...
Zydus' Generic Tadalafil Receives Approval in the U.S.
RARITAN, N.J., May 30, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today 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, World Health Organization [WHO] Group 1) in adult patients with WHO functional class (FC) II-III.1 The application is based on positive data from the Phase 3 A DUE study, which met its primary endpoint and demonstrated that M/T STCT significantly improved pulmonary hemodynamics (blood flow through pulmonary blood vessels) versus macitentan and tadalafil monotherapies in this PAH patient population.
Enforcement Report - Week of April 12, 2023
Enforcement Report - Week of March 8, 2023
With many pulmonary arterial hypertension (PAH) patients already taking Johnson & Johnson’s Opsumit (macitentan) or United Therapeutics' Adcirca (tadalafil), J&J has been pursuing a potential combination of the two therapies for several years.