Posted by Michael Wonder on 19 Apr 2021
United Therapeutics announces submission of Tvyaso DPI new drug application to FDA
19 April 2021 - Priority review voucher applied to the submission.
United Therapeutics today announced the submission of a new drug application to the U.S. FDA for Tyvaso DPI, a novel dry powder inhalation formulation of treprostinil, for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1 pulmonary hypertension) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3 pulmonary hypertension).
