🇺🇸 Byfavo in United States

FDA authorised Byfavo on 2 July 2020 · 67 US adverse-event reports

Marketing authorisations

FDA — authorised 2 July 2020

  • Application: NDA212295
  • Marketing authorisation holder: ACACIA
  • Status: supplemented

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. Vascular Access Site Occlusion — 11 reports (16.42%)
  2. Anaphylactic Reaction — 9 reports (13.43%)
  3. Hypotension — 8 reports (11.94%)
  4. Anaphylactic Shock — 7 reports (10.45%)
  5. Off Label Use — 7 reports (10.45%)
  6. Blood Pressure Decreased — 6 reports (8.96%)
  7. Cardiac Arrest — 5 reports (7.46%)
  8. Oxygen Saturation Decreased — 5 reports (7.46%)
  9. Tachycardia — 5 reports (7.46%)
  10. Bronchospasm — 4 reports (5.97%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Byfavo approved in United States?

Yes. FDA authorised it on 2 July 2020; FDA has authorised it.

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

ACACIA holds the US marketing authorisation.