🇺🇸 "Liraglutide" and "Mitiglinide" in United States

FDA authorised "Liraglutide" and "Mitiglinide" on 28 August 1981 · 2,111,531 US adverse-event reports

Marketing authorisations

FDA — authorised 28 August 1981

  • Application: ANDA086173
  • Marketing authorisation holder: FOSUN PHARMA
  • Status: supplemented

FDA — authorised 17 September 2010

  • Application: ANDA079025
  • Marketing authorisation holder: CHARTWELL RX
  • Status: approved

FDA — authorised 21 December 2011

  • Application: ANDA090653
  • Marketing authorisation holder: HOSPIRA INC
  • Status: approved

FDA — authorised 26 June 2012

  • Application: ANDA090979
  • Marketing authorisation holder: PADAGIS ISRAEL
  • Status: approved

FDA — authorised 12 September 2017

  • Application: ANDA206120
  • Marketing authorisation holder: XIROMED
  • Status: supplemented

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. Drug Ineffective — 322,450 reports (15.27%)
  2. Off Label Use — 247,356 reports (11.71%)
  3. Nausea — 247,198 reports (11.71%)
  4. Fatigue — 235,266 reports (11.14%)
  5. Diarrhoea — 195,881 reports (9.28%)
  6. Dyspnoea — 191,645 reports (9.08%)
  7. Headache — 184,660 reports (8.75%)
  8. Pain — 178,051 reports (8.43%)
  9. Dizziness — 157,609 reports (7.46%)
  10. Death — 151,415 reports (7.17%)

Source database →

Other Diabetes approved in United States

Frequently asked questions

Is "Liraglutide" and "Mitiglinide" approved in United States?

Yes. FDA authorised it on 28 August 1981; FDA authorised it on 17 September 2010; FDA authorised it on 21 December 2011.

Who is the marketing authorisation holder for "Liraglutide" and "Mitiglinide" in United States?

FOSUN PHARMA holds the US marketing authorisation.