🇺🇸 Omegaven in United States

FDA authorised Omegaven on 27 July 2018 · 126 US adverse-event reports

Marketing authorisations

FDA — authorised 27 July 2018

  • Application: NDA210589
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Status: approved

FDA

  • 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.

Most-reported reactions

  1. Fatty Acid Deficiency — 26 reports (20.63%)
  2. Off Label Use — 18 reports (14.29%)
  3. Intentional Product Use Issue — 16 reports (12.7%)
  4. Nausea — 11 reports (8.73%)
  5. Condition Aggravated — 10 reports (7.94%)
  6. Death — 10 reports (7.94%)
  7. Pyrexia — 10 reports (7.94%)
  8. Parenteral Nutrition Associated Liver Disease — 9 reports (7.14%)
  9. Pruritus — 8 reports (6.35%)
  10. Sepsis — 8 reports (6.35%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Omegaven approved in United States?

Yes. FDA authorised it on 27 July 2018; FDA has authorised it.

Who is the marketing authorisation holder for Omegaven in United States?

FRESENIUS KABI USA holds the US marketing authorisation.