🇺🇸 Levemir in United States

FDA authorised Levemir on 16 June 2005 · 18,863 US adverse-event reports

Marketing authorisations

FDA — authorised 16 June 2005

  • Application: BLA021536
  • Marketing authorisation holder: NOVO NORDISK INC
  • Status: supplemented

FDA — authorised 19 October 2005

  • Application: BLA021878
  • Marketing authorisation holder: NOVO NORDISK
  • Local brand name: LEVEMIR
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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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 — 6,286 reports (33.32%)
  2. Nausea — 1,959 reports (10.39%)
  3. Blood Glucose Decreased — 1,591 reports (8.43%)
  4. Fatigue — 1,528 reports (8.1%)
  5. Diarrhoea — 1,360 reports (7.21%)
  6. Drug Ineffective — 1,343 reports (7.12%)
  7. Vomiting — 1,276 reports (6.76%)
  8. Malaise — 1,191 reports (6.31%)
  9. Dyspnoea — 1,186 reports (6.29%)
  10. Dizziness — 1,143 reports (6.06%)

Source database →

Levemir 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 Levemir approved in United States?

Yes. FDA authorised it on 16 June 2005; FDA authorised it on 19 October 2005; FDA has authorised it.

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

NOVO NORDISK INC holds the US marketing authorisation.