🇺🇸 Hylenex in United States

FDA authorised Hylenex on 2 December 2005 · 160 US adverse-event reports

Marketing authorisations

FDA — authorised 2 December 2005

  • Application: BLA021859
  • Marketing authorisation holder: HALOZYME THERAP
  • 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. Hypersensitivity — 39 reports (24.38%)
  2. Off Label Use — 35 reports (21.88%)
  3. Drug Ineffective — 30 reports (18.75%)
  4. Swelling — 13 reports (8.12%)
  5. Burning Sensation — 10 reports (6.25%)
  6. Dry Eye — 7 reports (4.38%)
  7. Pain — 7 reports (4.38%)
  8. Swelling Face — 7 reports (4.38%)
  9. Arthralgia — 6 reports (3.75%)
  10. Erythema — 6 reports (3.75%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Hylenex approved in United States?

Yes. FDA authorised it on 2 December 2005; FDA has authorised it.

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

HALOZYME THERAP holds the US marketing authorisation.