🇺🇸 Eligard in United States

FDA authorised Eligard on 23 January 2002 · 49,834 US adverse-event reports

Marketing authorisations

FDA — authorised 23 January 2002

  • Application: NDA021343
  • Marketing authorisation holder: TOLMAR
  • Status: supplemented

FDA — authorised 24 July 2002

  • Application: NDA021379
  • Marketing authorisation holder: TOLMAR
  • Status: supplemented

FDA — authorised 13 February 2003

  • Application: NDA021488
  • Marketing authorisation holder: TOLMAR
  • Status: supplemented

FDA — authorised 14 December 2004

  • Application: NDA021731
  • Marketing authorisation holder: TOLMAR
  • 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. Intercepted Product Preparation Error — 8,679 reports (17.42%)
  2. Syringe Issue — 7,711 reports (15.47%)
  3. Hot Flush — 6,015 reports (12.07%)
  4. Device Leakage — 5,874 reports (11.79%)
  5. Death — 5,824 reports (11.69%)
  6. Wrong Technique In Product Usage Process — 5,095 reports (10.22%)
  7. Injection Site Pain — 4,128 reports (8.28%)
  8. Fatigue — 3,130 reports (6.28%)
  9. Prostatic Specific Antigen Increased — 1,749 reports (3.51%)
  10. Intentional Product Use Issue — 1,629 reports (3.27%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is Eligard approved in United States?

Yes. FDA authorised it on 23 January 2002; FDA authorised it on 24 July 2002; FDA authorised it on 13 February 2003.

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

TOLMAR holds the US marketing authorisation.