🇺🇸 LEUPROLIDE ACETATE in United States

FDA authorised LEUPROLIDE ACETATE on 25 October 2000 · 2,612 US adverse-event reports

Marketing authorisations

FDA — authorised 25 October 2000

  • Application: ANDA075471
  • Marketing authorisation holder: MEITHEAL
  • Status: supplemented

FDA — authorised 9 March 2009

  • Application: ANDA078885
  • Marketing authorisation holder: SUN PHARM
  • Status: supplemented

FDA — authorised 28 August 2018

  • Application: NDA205054
  • Marketing authorisation holder: INVAGEN PHARMS
  • Status: supplemented

FDA — authorised 13 August 2021

  • Application: ANDA213829
  • Marketing authorisation holder: SOMERSET THERAPS LLC
  • Status: approved

FDA — authorised 6 June 2022

  • Application: ANDA212963
  • Marketing authorisation holder: EUGIA PHARMA
  • 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. Drug Ineffective — 344 reports (13.17%)
  2. Fatigue — 336 reports (12.86%)
  3. Hot Flush — 270 reports (10.34%)
  4. Off Label Use — 268 reports (10.26%)
  5. Death — 256 reports (9.8%)
  6. Fall — 239 reports (9.15%)
  7. Asthenia — 233 reports (8.92%)
  8. Pneumonia — 229 reports (8.77%)
  9. Prostate Cancer — 226 reports (8.65%)
  10. Anaemia — 211 reports (8.08%)

Source database →

LEUPROLIDE ACETATE 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 LEUPROLIDE ACETATE approved in United States?

Yes. FDA authorised it on 25 October 2000; FDA authorised it on 9 March 2009; FDA authorised it on 28 August 2018.

Who is the marketing authorisation holder for LEUPROLIDE ACETATE in United States?

MEITHEAL holds the US marketing authorisation.