🇺🇸 Budesonide inhalation suspension in United States

FDA authorised Budesonide inhalation suspension on 16 November 2017 · 73 US adverse-event reports

Marketing authorisation

FDA — authorised 16 November 2017

  • Application: ANDA205710
  • Marketing authorisation holder: CIPLA
  • Status: supplemented

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 — 17 reports (23.29%)
  2. Liquid Product Physical Issue — 10 reports (13.7%)
  3. Poor Quality Product Administered — 10 reports (13.7%)
  4. Off Label Use — 7 reports (9.59%)
  5. Wrong Technique In Product Usage Process — 7 reports (9.59%)
  6. Product Quality Issue — 5 reports (6.85%)
  7. Product Use In Unapproved Indication — 5 reports (6.85%)
  8. Cough — 4 reports (5.48%)
  9. Drug Ineffective — 4 reports (5.48%)
  10. Product Packaging Quantity Issue — 4 reports (5.48%)

Source database →

Other Respiratory/Pulmonology approved in United States

Frequently asked questions

Is Budesonide inhalation suspension approved in United States?

Yes. FDA authorised it on 16 November 2017.

Who is the marketing authorisation holder for Budesonide inhalation suspension in United States?

CIPLA holds the US marketing authorisation.