🇺🇸 Basal insulin in United States

FDA authorised Basal insulin on 28 July 2021 · 54 US adverse-event reports

Marketing authorisations

FDA — authorised 28 July 2021

  • Application: BLA761201
  • Marketing authorisation holder: MYLAN PHARMS INC
  • Local brand name: SEMGLEE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 17 December 2021

  • Application: BLA761215
  • Marketing authorisation holder: ELI LILLY CO
  • Local brand name: REZVOGLAR
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

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. Diabetic Ketoacidosis — 10 reports (18.52%)
  2. Nausea — 7 reports (12.96%)
  3. Hypoglycaemia — 6 reports (11.11%)
  4. Vomiting — 6 reports (11.11%)
  5. Blood Glucose Increased — 5 reports (9.26%)
  6. Blood Glucose Decreased — 4 reports (7.41%)
  7. Dizziness — 4 reports (7.41%)
  8. Ketoacidosis — 4 reports (7.41%)
  9. Off Label Use — 4 reports (7.41%)
  10. Sepsis — 4 reports (7.41%)

Source database →

Basal insulin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Basal insulin approved in United States?

Yes. FDA authorised it on 28 July 2021; FDA authorised it on 17 December 2021; FDA has authorised it.

Who is the marketing authorisation holder for Basal insulin in United States?

MYLAN PHARMS INC holds the US marketing authorisation.