Yutrepia FDA Approval Status
Last updated by Judith Stewart, BPharm on Aug 20, 2024.
FDA Approved: No (Tentative Approval)
Brand name: Yutrepia
Generic name: treprostinil
Dosage form: Inhalation Powder
Previous Name: LIQ861
Company: Liquidia Technologies, Inc.
Treatment for: Pulmonary Arterial Hypertension; Pulmonary Hypertension Associated with Interstitial Lung Disease
Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil tentatively approved for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
- On November 8, 2021, the U.S. Food and Drug Administration (FDA) granted tentative approval for Yutrepia for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability in adult patients with NYHA Functional Class II-III symptoms.
- On August 16, 2024, the FDA granted tentative approval for Yutrepia to treat adults with PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
- Tentative approval indicates that Yutrepia has met all regulatory standards for quality, safety and efficacy required for approval in the United States but must await the expiration of regulatory exclusivity of a competing product before final approval can be granted.
Development timeline for Yutrepia
Further information
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