🇺🇸 Lupron in United States

FDA authorised Lupron on 26 January 1989 · 23,828 US adverse-event reports

Marketing authorisations

FDA — authorised 26 January 1989

  • Application: NDA019732
  • Marketing authorisation holder: ABBVIE ENDOCRINE INC
  • Status: supplemented

FDA — authorised 22 October 1990

  • Application: NDA020011
  • Marketing authorisation holder: ABBVIE ENDOCRINE INC
  • Status: supplemented

FDA — authorised 16 April 1993

  • Application: NDA020263
  • Marketing authorisation holder: ABBVIE ENDOCRINE INC
  • Status: supplemented

FDA — authorised 22 December 1995

  • Application: NDA020517
  • Marketing authorisation holder: ABBVIE ENDOCRINE INC
  • Status: supplemented

FDA — authorised 7 March 1997

  • Application: NDA020708
  • Marketing authorisation holder: ABBVIE ENDOCRINE 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. Hot Flush — 4,814 reports (20.2%)
  2. Fatigue — 3,692 reports (15.49%)
  3. Death — 3,035 reports (12.74%)
  4. Headache — 2,117 reports (8.88%)
  5. Pain — 2,011 reports (8.44%)
  6. Nausea — 1,832 reports (7.69%)
  7. Arthralgia — 1,718 reports (7.21%)
  8. Asthenia — 1,634 reports (6.86%)
  9. Drug Ineffective — 1,522 reports (6.39%)
  10. Dizziness — 1,453 reports (6.1%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Lupron approved in United States?

Yes. FDA authorised it on 26 January 1989; FDA authorised it on 22 October 1990; FDA authorised it on 16 April 1993.

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

ABBVIE ENDOCRINE INC holds the US marketing authorisation.