www.fdanews.com/articles/184117-fda-approves-new-nebulizer-for-tyvaso-inhalation-system
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FDA Approves New Nebulizer for Tyvaso Inhalation System
October 25, 2017
United Therapeutics received FDA approval for its TD-300/A inhalation device for use with its Tyvaso (treprostinil) inhalation solution.
Tyvaso is a prostacyclin, pulmonary, and systemic vasodilator indicated for the treatment of pulmonary arterial hypertension to improve exercise ability.
Tyvaso was originally approved by the FDA for the treatment of PAH in 2009, under a new drug application covering a drug-device combination product consisting of Tyvaso drug product, as well as an ultrasonic nebulizer and accessories, referred to as the Tyvaso inhalation system.