🇺🇸 Insulin glargine U100 in United States

FDA authorised Insulin glargine U100 on 16 December 2015 · 8 US adverse-event reports

Marketing authorisation

FDA — authorised 16 December 2015

  • Application: BLA205692
  • Marketing authorisation holder: ELI LILLY AND CO
  • Local brand name: BASAGLAR
  • 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. Abdominal Pain Upper — 1 report (12.5%)
  2. Acute Kidney Injury — 1 report (12.5%)
  3. Amylase Increased — 1 report (12.5%)
  4. Fatigue — 1 report (12.5%)
  5. International Normalised Ratio Increased — 1 report (12.5%)
  6. Lactic Acidosis — 1 report (12.5%)
  7. Lipase Increased — 1 report (12.5%)
  8. Metabolic Acidosis — 1 report (12.5%)

Source database →

Other Diabetes approved in United States

Frequently asked questions

Is Insulin glargine U100 approved in United States?

Yes. FDA authorised it on 16 December 2015.

Who is the marketing authorisation holder for Insulin glargine U100 in United States?

ELI LILLY AND CO holds the US marketing authorisation.