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# Liquidia Expects FDA Yutrepia Final OK Soon
- URL: https://www.fdaweb.com/liquidia-expects-fda-yutrepia-final-ok-soon/
- Published: 2024-04-04T12:00:00.000Z
- Updated: 2026-09-14T14:27:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156707

Liquidia says it has submitted to FDA a 3/28 decision by the Delaware federal court setting aside an injunction that it issued in 8/2022 in a suit filed by United Therapeutics to prevent the agency from granting final approval to Liquidia’s Yutrepia (treprostinil) inhalation powder. A Liquidia [statement](https://liquidia.com/news-releases/news-release-details/update-favorable-legal-and-regulatory-outcomes-clearing-path?ref=fdaweb.com) says FDA is no longer enjoined from approving the company’s NDA and “\[we\] look forward to a decision from FDA in the near future.”

The company says FDA tentatively approved Yutrepia to treat pulmonary arterial hypertension in 11/2021\. Liquidia amended its NDA in 7/2023 to add an indication to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Liquidia reports that United Therapeutics has filed a notice of appeal on the court’s decision to set aside the injunction. It also has filed new lawsuits seeking injunctions to prevent the launch of Yutrepia to treat PH-ILD. “None of these appeals or actions will impede the company’s launch of Yutrepia unless United Therapeutics is successful in obtaining the relief it is seeking,” it says.

Yutrepia is described as an investigational, inhaled dry powder formulation of treprostinil delivered through a palm-sized device.