For parenteral nutrition-associated cholestasis (PNAC). Sold as Omegaven. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Fish Oil Triglycerides (sold as Omegaven), first approved Jul 27, 2018, with 0 new uses approved and 0 published complete response letters.
| Intravenous Fish Oil Emulsion in Critically Ill Patients With High Inflammatory Status.Critical Illness · Lee Zheng Yii | Phase 2 | Recruiting | Oct 20, 2026 |
| NutrImmune: Precision Nutrition to Improve Immunity in Individuals With ObesityObesity (BMI>30), Immune Abnormalities · Institut National de la Santé Et de la Recherche Médicale, France | Not applicable | Not yet recruiting | Sep 30, 2026 |
| Butyrate or Intensive Lifestyle Modification in Type 1 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver DiseaseType 1 Diabetes · Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | Not applicable | Not yet recruiting | Jul 6, 2026 |
| Preoperative Fish Oil PN and Prognosis After Constipation SurgeryConstipation, Slow Transit Constipation · Qianfoshan Hospital | — | Not yet recruiting | Mar 13, 2026 |
| Effects of Omega-3 Fatty Acids on Acute Graft-versus-Host Disease After Allogeneic Stem Cell Transplantation.Graft-Versus-Host Disease(GVHD) · Fujian Medical University | Phase 1 / Phase 2 | Enrolling by invitation | Sep 9, 2025 |
| A Study in Healthy Subjects to Compare the Bioavailability of EPA + DHAOptimal Absorption of Omega-3, Healthy · RDC Clinical Pty Ltd | Phase 4 | Recruiting | Oct 8, 2024 |
| Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery PatientsIntensive Care Unit, Coronary Artery Bypass Grafting (CABG) · GCP-Service International West GmbH | Phase 2 | Recruiting | Feb 28, 2024 |
| Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven TreatmentParenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency · Fresenius Kabi | — | Recruiting | Feb 23, 2024 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jul 27, 2018 | OmegavenNDA 210589 · New molecular entity, new combination | Fresenius Kabi USA | 3 | 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
Fresenius Kabi USA