Posted by Michael Wonder on 18 Oct 2021
United Therapeutics provides an update on the progress of the Tyvaso DPI new drug application
18 October 2021 - Draft label contains both PAH and PH-ILD indications; no contra-indications and no boxed warning.
United Therapeutics today announced an update on the U.S. FDA review of the new drug application for Tyvaso DPI, for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, to improve exercise capacity.
On 15 October 2021, the FDA issued a complete response declining to approve the new drug application at this time.
