FDA — authorised 7 April 2014
- Application: ANDA091028
- Marketing authorisation holder: GLW
- Indication: Labeling
- Status: approved
🇺🇸 omega in United States
FDA authorised omega on 7 April 2014 · 27,775 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: 27,775
Most-reported reactions
- Fatigue — 4,254 reports (15.32%)
- Nausea — 3,139 reports (11.3%)
- Diarrhoea — 3,105 reports (11.18%)
- Drug Ineffective — 2,937 reports (10.57%)
- Headache — 2,858 reports (10.29%)
- Pain — 2,488 reports (8.96%)
- Arthralgia — 2,398 reports (8.63%)
- Dizziness — 2,360 reports (8.5%)
- Dyspnoea — 2,160 reports (7.78%)
- Off Label Use — 2,076 reports (7.47%)
omega in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is omega 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 in United States?
GLW holds the US marketing authorisation.