Sold as Yutrepia. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Treprostinil Sodium (sold as Yutrepia), first approved May 23, 2025, with 0 new uses approved and 0 published complete response letters.
| Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAHPulmonary Arterial Hypertension · AOP Orphan Pharmaceuticals AG | Phase 3 | Recruiting | Apr 5, 2024 |
| Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I PatientsPulmonary Arterial Hypertension · AOP Orphan Pharmaceuticals AG | Phase 4 | Recruiting | Mar 19, 2024 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| May 23, 2025 | YutrepiaNDA 213005 · New formulation or manufacturer | Liquidia Tech | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
