FDA · United States
omega-3-acid ethyl esters — FDA regulatory status
omega-3-acid ethyl esters (OMEGA-3-ACID ETHYL ESTERS) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- OMEGA-3-ACID ETHYL ESTERS
- Originator
- Amneal Pharma Europe Ltd
- Mechanism
- Unknown
- Structured fields
- 6
Sponsor / originator context: Amneal Pharma Europe Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Unknown. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 8 published clinical programs and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| omega-3-acid ethyl esters 90 (TAK-085) | Phase 3 | Takeda | NCT01350973, NCT01350999 |
| Azacitidine (AZA) with Ruxolitinib | Phase 2 | First People's Hospital | NCT05817955 |
| Lovaza, omega-3 fatty acid ethyl ester | Phase 2 | United Therapeutics Europe | NCT01216982 |
| CA235-0001 | Phase 1 | Bristol-Myers Squibb Australia | 2024-519537-29-00 |
| Omega-3 fatty acids | Phase 1 | NORTHWEST BIOTHERAPEUTICS | NCT00350194 |
| TAK-085 | Approved | Takeda | NCT02839902, NCT02824432 |
| Omega-3 | Unknown | Chinese Academy of | NCT07348562 |
| omega-3 polyunsaturated fatty acids | Unknown | Chinese Academy of | NCT06061510 |
Related hubs
FAQ
What is the FDA approval status of omega-3-acid ethyl esters?
omega-3-acid ethyl esters currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get omega-3-acid ethyl esters regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to omega-3-acid ethyl esters?
This spoke lists 8 published programs associated with omega-3-acid ethyl esters in our pipeline index.