Posted by Michael Wonder on 24 Oct 2017
United Therapeutics announces FDA approval of third generation nebuliser for the Tyvaso inhalation system
23 October 2017 - United Therapeutics today announced approval by the U.S. FDA of a new inhalation device, called the TD-300/A, for use with Tyvaso (treprostinil) Inhalation Solution (Tyvaso).
Tyvaso was originally approved by the FDA for the treatment of pulmonary arterial hypertension (PAH) in 2009, under a New Drug Application covering a drug-device combination product consisting of Tyvaso drug product, as well as an ultrasonic nebuliser and accessories referred to as the Tyvaso Inhalation System.
Tyvaso is the most-prescribed inhalation therapy for PAH in the United States, and since its launch, United Therapeutics has been working on improvements to the Tyvaso Inhalation System to aid patient compliance and enhance ease of use.
