🇺🇸 Albumin in United States

FDA authorised Albumin on 7 January 2005 · 4,992 US adverse-event reports

Marketing authorisations

FDA — authorised 7 January 2005

  • Application: NDA021660
  • Marketing authorisation holder: BRISTOL-MYERS
  • Status: supplemented

FDA — authorised 27 July 2022

  • Application: NDA211875
  • Marketing authorisation holder: AM REGENT
  • Status: approved

FDA — authorised 15 May 2025

  • Application: ANDA216355
  • Marketing authorisation holder: SHUANGCHENG
  • Status: approved

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. Pyrexia — 620 reports (12.42%)
  2. Renal Failure — 557 reports (11.16%)
  3. Pneumonia — 544 reports (10.9%)
  4. Off Label Use — 536 reports (10.74%)
  5. Diarrhoea — 516 reports (10.34%)
  6. Drug Ineffective — 464 reports (9.29%)
  7. Dyspnoea — 457 reports (9.15%)
  8. Hypotension — 446 reports (8.93%)
  9. Sepsis — 428 reports (8.57%)
  10. Pain — 424 reports (8.49%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Albumin approved in United States?

Yes. FDA authorised it on 7 January 2005; FDA authorised it on 27 July 2022; FDA authorised it on 15 May 2025.

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

BRISTOL-MYERS holds the US marketing authorisation.