FDA — authorised 7 April 2014
- Application: ANDA091028
- Marketing authorisation holder: GLW
- Indication: Labeling
- Status: approved
🇺🇸 Omega 3 in United States
FDA authorised Omega 3 on 7 April 2014 · 25,269 US adverse-event reports
Marketing authorisations
FDA — authorised 27 November 2015
- Application: ANDA204940
- Marketing authorisation holder: AMNEAL PHARMS
- Status: approved
FDA — authorised 19 September 2017
- Application: ANDA203893
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Indication: Labeling
- Status: approved
FDA — authorised 25 February 2019
- Application: ANDA207420
- Marketing authorisation holder: ASCENT PHARMS INC
- Status: approved
FDA — authorised 7 August 2019
- Application: ANDA206455
- Marketing authorisation holder: CHARTWELL
- Status: approved
FDA — authorised 15 November 2021
- Application: ANDA215458
- Marketing authorisation holder: MANKIND PHARMA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 25,269
Most-reported reactions
- Fatigue — 3,931 reports (15.56%)
- Nausea — 2,876 reports (11.38%)
- Diarrhoea — 2,839 reports (11.24%)
- Drug Ineffective — 2,684 reports (10.62%)
- Headache — 2,539 reports (10.05%)
- Pain — 2,243 reports (8.88%)
- Arthralgia — 2,166 reports (8.57%)
- Dizziness — 2,115 reports (8.37%)
- Dyspnoea — 1,949 reports (7.71%)
- Off Label Use — 1,927 reports (7.63%)
Omega 3 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Omega 3 approved in United States?
Yes. FDA authorised it on 7 April 2014; FDA authorised it on 27 November 2015; FDA authorised it on 19 September 2017.
Who is the marketing authorisation holder for Omega 3 in United States?
GLW holds the US marketing authorisation.