🇺🇸 Adagen in United States

FDA authorised Adagen on 21 March 1990 · 60 US adverse-event reports

Marketing authorisation

FDA — authorised 21 March 1990

  • Application: BLA019818
  • Marketing authorisation holder: LEADIANT BIOSCI INC
  • Local brand name: ADAGEN
  • 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. Infection — 8 reports (13.33%)
  2. Dermatofibrosarcoma Protuberans — 7 reports (11.67%)
  3. Haemolytic Anaemia — 7 reports (11.67%)
  4. Respiratory Failure — 7 reports (11.67%)
  5. Death — 6 reports (10%)
  6. Hepatic Enzyme Increased — 6 reports (10%)
  7. Diarrhoea — 5 reports (8.33%)
  8. Pneumonia — 5 reports (8.33%)
  9. Respiratory Tract Infection — 5 reports (8.33%)
  10. B-Cell Lymphoma — 4 reports (6.67%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Adagen approved in United States?

Yes. FDA authorised it on 21 March 1990.

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

LEADIANT BIOSCI INC holds the US marketing authorisation.