FDA Approves New Inhalation Device for Use With Tyvaso. United The.utics announced that the Food and Drug Administration FDA has approved TD A, a new inhalation device for use with Tyvaso treprostinil inhalation solution..The FDA has approved an updated nebulizer for use with United The.utics Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial . United The.utics Announces FDA Approval Of Third Generation of a new inhalation device,ed the TD A, for use with Tyvaso . The U.S. Food and Drug Administration FDA has approved a new, third generation inhalation device, the TD A, for use with Tyvaso .
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Tyvaso is approved to treat pulmonary arterial hypertension
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.