🇺🇸 Degludec in United States

FDA authorised Degludec on 25 September 2015 · 2,183 US adverse-event reports

Marketing authorisations

FDA — authorised 25 September 2015

  • Application: BLA203314
  • Marketing authorisation holder: NOVO
  • Status: supplemented

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. Nausea — 278 reports (12.73%)
  2. Vomiting — 258 reports (11.82%)
  3. General Physical Health Deterioration — 223 reports (10.22%)
  4. Off Label Use — 222 reports (10.17%)
  5. Stress — 210 reports (9.62%)
  6. Abdominal Pain — 208 reports (9.53%)
  7. Ascites — 199 reports (9.12%)
  8. Hyponatraemia — 199 reports (9.12%)
  9. Sepsis — 194 reports (8.89%)
  10. Constipation — 192 reports (8.8%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Degludec approved in United States?

Yes. FDA authorised it on 25 September 2015; FDA has authorised it.

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

NOVO holds the US marketing authorisation.