🇺🇸 Amphotericin B Liposome in United States

FDA authorised Amphotericin B Liposome on 30 June 2025 · 2,139 US adverse-event reports

Marketing authorisations

FDA — authorised 30 June 2025

  • Application: ANDA212967
  • Marketing authorisation holder: MYLAN LABS LTD
  • 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. Drug Ineffective — 1,069 reports (49.98%)
  2. Off Label Use — 384 reports (17.95%)
  3. Death — 113 reports (5.28%)
  4. Acute Kidney Injury — 104 reports (4.86%)
  5. Pyrexia — 90 reports (4.21%)
  6. Hypokalaemia — 86 reports (4.02%)
  7. Multiple Organ Dysfunction Syndrome — 83 reports (3.88%)
  8. Treatment Failure — 79 reports (3.69%)
  9. Pancytopenia — 69 reports (3.23%)
  10. Renal Impairment — 62 reports (2.9%)

Source database →

Amphotericin B Liposome 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 Amphotericin B Liposome approved in United States?

Yes. FDA authorised it on 30 June 2025; FDA has authorised it.

Who is the marketing authorisation holder for Amphotericin B Liposome in United States?

MYLAN LABS LTD holds the US marketing authorisation.