🇺🇸 androgen deprivation therapy in United States

FDA authorised androgen deprivation therapy on 26 January 1989 · 12 US adverse-event reports

Marketing authorisation

FDA — authorised 26 January 1989

  • Application: NDA019732
  • Marketing authorisation holder: ABBVIE ENDOCRINE INC
  • Local brand name: LUPRON DEPOT
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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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. Fatigue — 2 reports (16.67%)
  2. Prostatic Specific Antigen Increased — 2 reports (16.67%)
  3. Abdominal Discomfort — 1 report (8.33%)
  4. Abdominal Pain Upper — 1 report (8.33%)
  5. Androgen Deficiency — 1 report (8.33%)
  6. Aspiration — 1 report (8.33%)
  7. Asthenia — 1 report (8.33%)
  8. Back Pain — 1 report (8.33%)
  9. Deep Vein Thrombosis — 1 report (8.33%)
  10. Diarrhoea — 1 report (8.33%)

Source database →

Frequently asked questions

Is androgen deprivation therapy approved in United States?

Yes. FDA authorised it on 26 January 1989.

Who is the marketing authorisation holder for androgen deprivation therapy in United States?

ABBVIE ENDOCRINE INC holds the US marketing authorisation.