🇺🇸 Victoza in United States

FDA authorised Victoza on 25 January 2010 · 26,293 US adverse-event reports

Marketing authorisations

FDA — authorised 25 January 2010

  • Application: NDA022341
  • 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. Nausea — 6,148 reports (23.38%)
  2. Blood Glucose Increased — 4,043 reports (15.38%)
  3. Diarrhoea — 2,930 reports (11.14%)
  4. Vomiting — 2,775 reports (10.55%)
  5. Pancreatitis — 2,174 reports (8.27%)
  6. Weight Decreased — 2,013 reports (7.66%)
  7. Decreased Appetite — 1,934 reports (7.36%)
  8. Headache — 1,694 reports (6.44%)
  9. Off Label Use — 1,295 reports (4.93%)
  10. Fatigue — 1,287 reports (4.89%)

Source database →

Victoza 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 Victoza approved in United States?

Yes. FDA authorised it on 25 January 2010; FDA has authorised it.

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

NOVO NORDISK INC holds the US marketing authorisation.