United Therapeutics (UTHR) Tops Q3 EPS by 82c, Beats on Revenues

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United Therapeutics (UTHR) Granted FDA Approval Of Third Generation Nebulizer For Tyvaso Inhalation System

October 23, 2017 6:00 AM EDT

United Therapeutics Corporation (NASDAQ: UTHR) today announced approval by the U.S. Food and Drug Administration (FDA) of a new inhalation device, called the TD-300/A, for use with Tyvaso® (treprostinil) Inhalation Solution (Tyvaso).

Tyvaso was originally approved by the FDA for the treatment of pulmonary arterial hypertension (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. Tyvaso is the most-prescribed inhalation therapy for PAH in the United States, and... More