FDA Approves New Inhalation Device for Use With Tyvaso

Remodulin UT [United The.utics] FDA Gentiva.

Remodulin UT [United The.utics] FDA Gentiva.

Tyvaso is approved to treat pulmonary arterial hypertension

Tyvaso is approved to treat pulmonary arterial hypertension

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. 

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