First approval of a dry powder inhaler for treatment of PAH and PH-ILD DPI device represents a convenient option for administration of treprostinil therapy Commercial launch activities underway; patient availability expected in June 2022 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–United Therapeutics Corporation (Nasdaq: UTHR), a public benefit […]
Tag: Tyvaso DPI
United Therapeutics Announces FDA Acceptance of Tyvaso DPI™ New Drug Application For Priority Review
FDA action expected in October 2021 SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., June 16, 2021 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for Tyvaso DPI™ (inhaled treprostinil) for the treatment of pulmonary arterial hypertension […]
United Therapeutics Announces BREEZE Study of Investigational Tyvaso DPI™ Meets Primary Objective
Study demonstrated safety and tolerability of Tyvaso DPI™ in patients with PAH transitioning from Tyvaso® Inhalation Solution A separate study in healthy volunteers demonstrated comparable treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution Tyvaso DPI NDA filing anticipated in April 2021 with priority review SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, […]