🇺🇸 Novolog in United States

FDA authorised Novolog on 7 June 2000 · 30,228 US adverse-event reports

Marketing authorisations

FDA — authorised 7 June 2000

  • Application: BLA020986
  • Marketing authorisation holder: NOVO NORDISK INC
  • Status: supplemented

FDA — authorised 1 November 2001

  • Application: BLA021172
  • Marketing authorisation holder: NOVO NORDISK INC
  • 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. Blood Glucose Increased — 9,645 reports (31.91%)
  2. Nausea — 3,130 reports (10.35%)
  3. Blood Glucose Decreased — 3,128 reports (10.35%)
  4. Drug Ineffective — 2,793 reports (9.24%)
  5. Fatigue — 2,267 reports (7.5%)
  6. Diarrhoea — 2,136 reports (7.07%)
  7. Dyspnoea — 1,941 reports (6.42%)
  8. Vomiting — 1,812 reports (5.99%)
  9. Dizziness — 1,706 reports (5.64%)
  10. Weight Decreased — 1,670 reports (5.52%)

Source database →

Other Metabolic approved in United States

Frequently asked questions

Is Novolog approved in United States?

Yes. FDA authorised it on 7 June 2000; FDA authorised it on 1 November 2001; FDA has authorised it.

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

NOVO NORDISK INC holds the US marketing authorisation.