Redesigned Inhalation Device for PAH Approved by FDA
The FDA has approved TD-300/A, a new inhalation device for use with Tyvaso inhalation solution.
United Therapeutics announced that the Food and Drug Administration (FDA) has approved TD-300/A, a new inhalation device for use with Tyvaso (treprostinil) inhalation solution.
Tyvaso, a prostacyclin vasodilator, was initially approved in 2009 for the treatment of pulmonary arterial hypertension (PAH) WHO Group 1 to improve exercise ability. The approval was for a drug-device combination product consisting of Tyvaso plus an ultrasonic nebulizer and accessories.
The new device, TD-300/A, features a more ergonomic design with a single-button operation, an intuitive user interface to adjust breath counts, an internal, rechargeable battery, and a color graphical display that guides patients through the inhalation process and shows the time since last treatment.
"The launch [...] will further optimize Tyvaso therapy for patients and, we believe, reduce the rate of therapy discontinuation associated with the current nebulizer." TD-300/A is anticipated to launch in the middle of 2018.
United therapeutics announces FDA approval of third generation nebulizer for the Tyvaso inhalation system [press release]. Silver Spring, Maryland: United Therapeutics Corporation; October 23, 2017. Accessed November 1, 2017.