FDA Approves New Nebulizer for Tyvaso Inhalation System

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.