The following adverse reaction has been identified during the post approval use of Tyvaso. the FDA approved a new inhalation device your specialty . FDA of a new inhalation device, Tyvaso was originally approved by the FDA for the treatment of United The.utics Corporation is a biotechnology .
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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.