🇺🇸 Anoro in United States

FDA authorised Anoro on 18 December 2013 · 10,864 US adverse-event reports

Marketing authorisations

FDA — authorised 18 December 2013

  • Application: NDA203975
  • Marketing authorisation holder: GLAXOSMITHKLINE
  • 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 — 2,333 reports (21.47%)
  2. Drug Ineffective — 1,605 reports (14.77%)
  3. Wrong Technique In Device Usage Process — 1,576 reports (14.51%)
  4. Product Complaint — 1,134 reports (10.44%)
  5. Cough — 1,088 reports (10.01%)
  6. Product Dose Omission Issue — 846 reports (7.79%)
  7. Pneumonia — 676 reports (6.22%)
  8. Chronic Obstructive Pulmonary Disease — 619 reports (5.7%)
  9. Drug Dispensing Error — 496 reports (4.57%)
  10. Condition Aggravated — 491 reports (4.52%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Anoro approved in United States?

Yes. FDA authorised it on 18 December 2013; FDA has authorised it.

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

GLAXOSMITHKLINE holds the US marketing authorisation.