🇺🇸 Advair in United States

FDA authorised Advair on 24 August 2000 · 88,728 US adverse-event reports

Marketing authorisations

FDA — authorised 24 August 2000

  • Application: NDA021077
  • Marketing authorisation holder: GLAXO GRP LTD
  • Status: supplemented

FDA — authorised 8 June 2006

  • Application: NDA021254
  • Marketing authorisation holder: GLAXO GRP LTD
  • 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. Dyspnoea — 19,141 reports (21.57%)
  2. Drug Ineffective — 13,002 reports (14.65%)
  3. Asthma — 11,388 reports (12.83%)
  4. Cough — 8,514 reports (9.6%)
  5. Pneumonia — 8,172 reports (9.21%)
  6. Fatigue — 5,984 reports (6.74%)
  7. Wheezing — 5,672 reports (6.39%)
  8. Product Quality Issue — 5,643 reports (6.36%)
  9. Malaise — 5,610 reports (6.32%)
  10. Headache — 5,602 reports (6.31%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Advair approved in United States?

Yes. FDA authorised it on 24 August 2000; FDA authorised it on 8 June 2006; FDA has authorised it.

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

GLAXO GRP LTD holds the US marketing authorisation.