🇺🇸 Xolair in United States

FDA authorised Xolair on 20 June 2003 · 64,964 US adverse-event reports

Marketing authorisations

FDA — authorised 20 June 2003

  • Application: BLA103976
  • Marketing authorisation holder: GENENTECH
  • 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. No Adverse Event — 10,114 reports (15.57%)
  2. Off Label Use — 9,205 reports (14.17%)
  3. Urticaria — 8,172 reports (12.58%)
  4. Asthma — 7,935 reports (12.21%)
  5. Dyspnoea — 6,576 reports (10.12%)
  6. Drug Ineffective — 5,866 reports (9.03%)
  7. Pruritus — 4,469 reports (6.88%)
  8. Fatigue — 4,373 reports (6.73%)
  9. Cough — 4,316 reports (6.64%)
  10. Headache — 3,938 reports (6.06%)

Source database →

Xolair in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Respiratory approved in United States

Frequently asked questions

Is Xolair approved in United States?

Yes. FDA authorised it on 20 June 2003; FDA has authorised it.

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

GENENTECH holds the US marketing authorisation.