🇺🇸 Insulin glargine/Lixisenatide in United States

FDA authorised Insulin glargine/Lixisenatide on 21 November 2016 · 145 US adverse-event reports

Marketing authorisation

FDA — authorised 21 November 2016

  • Application: BLA208673
  • Marketing authorisation holder: SANOFI-AVENTIS US
  • Local brand name: SOLIQUA 100/33
  • Indication: SOLUTION — SUBCUTANEOUS
  • Status: approved

Read official source →

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 — 29 reports (20%)
  2. Hypoglycaemia — 18 reports (12.41%)
  3. Diarrhoea — 17 reports (11.72%)
  4. Nausea — 17 reports (11.72%)
  5. Weight Decreased — 16 reports (11.03%)
  6. Decreased Appetite — 10 reports (6.9%)
  7. Injection Site Pain — 10 reports (6.9%)
  8. Vomiting — 10 reports (6.9%)
  9. Abdominal Discomfort — 9 reports (6.21%)
  10. Feeling Abnormal — 9 reports (6.21%)

Source database →

Other Diabetes approved in United States

Frequently asked questions

Is Insulin glargine/Lixisenatide approved in United States?

Yes. FDA authorised it on 21 November 2016.

Who is the marketing authorisation holder for Insulin glargine/Lixisenatide in United States?

SANOFI-AVENTIS US holds the US marketing authorisation.