Posted by Michael Wonder on 16 Jun 2021
United Therapeutics announces FDA acceptance of Tyvaso DPI new drug application for priority review
16 June 2021 - FDA action expected in October 2021.
United Therapeutics today announced that the U.S. FDA accepted for priority review the new drug application for Tyvaso DPI (inhaled treprostinil) for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
United Therapeutics expects the agency’s review to be complete in October 2021. The FDA also indicated that they have not identified any potential review issues at this time.
