🇺🇸 Bupivacaine liposome in United States

FDA authorised Bupivacaine liposome on 1 July 2024 · 24 US adverse-event reports

Marketing authorisation

FDA — authorised 1 July 2024

  • Application: ANDA214348
  • Marketing authorisation holder: HENGRUI PHARMA
  • Local brand name: BUPIVACAINE LIPOSOME
  • Indication: INJECTABLE, LIPOSOMAL — INJECTION
  • Status: approved

Read official source →

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. Pain — 4 reports (16.67%)
  2. Bradycardia — 3 reports (12.5%)
  3. Post Procedural Haematoma — 3 reports (12.5%)
  4. Arrhythmia — 2 reports (8.33%)
  5. Blister — 2 reports (8.33%)
  6. Breast Haematoma — 2 reports (8.33%)
  7. Ecchymosis — 2 reports (8.33%)
  8. Hypoaesthesia — 2 reports (8.33%)
  9. Hypotension — 2 reports (8.33%)
  10. Nausea — 2 reports (8.33%)

Source database →

Other Anesthesia/Pain Management approved in United States

Frequently asked questions

Is Bupivacaine liposome approved in United States?

Yes. FDA authorised it on 1 July 2024.

Who is the marketing authorisation holder for Bupivacaine liposome in United States?

HENGRUI PHARMA holds the US marketing authorisation.