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# Tyvaso DPI Pulmonary Hypertension NDA Accepted
- URL: https://www.fdaweb.com/tyvaso-dpi-pulmonary-hypertension-nda-accepted/
- Published: 2021-06-16T12:00:00.000Z
- Updated: 2026-09-14T17:03:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149548

FDA has accepted for priority review a United Therapeutics NDA for Tyvaso DPI (inhaled treprostinil) for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease. The company says it expects a review decision in October.

The submission includes [data](https://c212.net/c/link/?t=0&l=en&o=3197895-1&h=1889251413&u=https%3A%2F%2Fir.unither.com%2Fnews%2Fpress-releases%2Fpress-release-details%2F2021%2FUnited-Therapeutics-Announces-BREEZE-Study-of-Investigational-Tyvaso-DPI-Meets-Primary-Objective%2Fdefault.aspx&a=data&ref=fdaweb.com) from the *BREEZE* clinical study that demonstrated safety and tolerability of Tyvaso DPI in patients with PAH transitioning from Tyvaso (treprostinil) Inhalation Solution. “A separate study in healthy volunteers demonstrated comparable treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution,” United Therapeutics says.

The product was formulated with development partner MannKind and its dry powder formulation technology and Dreamboat inhalation device technology used in MannKind’s Afrezza (insulin human) Inhalation Powder, which was approved in 2014\. The companies say they are also developing BluHale, a Bluetooth-connected accessory for the Tyvaso DPI inhaler with a companion mobile application intended to help patients track information about their inhaler use.