🇺🇸 Breztri Aerosphere in United States

FDA authorised Breztri Aerosphere on 23 July 2020 · 553 US adverse-event reports

Marketing authorisations

FDA — authorised 23 July 2020

  • Application: NDA212122
  • Marketing authorisation holder: ASTRAZENECA AB
  • Local brand name: BREZTRI AEROSPHERE
  • Indication: AEROSOL, METERED — INHALATION
  • Status: approved

Read official source →

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 — 126 reports (22.78%)
  2. Device Malfunction — 61 reports (11.03%)
  3. Wrong Technique In Device Usage Process — 60 reports (10.85%)
  4. Cough — 54 reports (9.76%)
  5. Drug Ineffective — 52 reports (9.4%)
  6. Intentional Device Misuse — 46 reports (8.32%)
  7. Device Delivery System Issue — 44 reports (7.96%)
  8. Product Dose Omission Issue — 38 reports (6.87%)
  9. Death — 37 reports (6.69%)
  10. Incorrect Dose Administered By Device — 35 reports (6.33%)

Source database →

Breztri Aerosphere in other countries

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

Frequently asked questions

Is Breztri Aerosphere approved in United States?

Yes. FDA authorised it on 23 July 2020; FDA has authorised it.

Who is the marketing authorisation holder for Breztri Aerosphere in United States?

ASTRAZENECA AB holds the US marketing authorisation.