🇺🇸 Afrezza in United States

FDA authorised Afrezza on 27 June 2014 · 1,216 US adverse-event reports

Marketing authorisations

FDA — authorised 27 June 2014

  • Application: BLA022472
  • Marketing authorisation holder: MANNKIND
  • 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. Blood Glucose Increased — 360 reports (29.61%)
  2. Cough — 319 reports (26.23%)
  3. Drug Ineffective — 212 reports (17.43%)
  4. Blood Glucose Decreased — 102 reports (8.39%)
  5. Dyspnoea — 58 reports (4.77%)
  6. Throat Irritation — 49 reports (4.03%)
  7. Blood Glucose Abnormal — 29 reports (2.38%)
  8. Blood Glucose Fluctuation — 29 reports (2.38%)
  9. Chest Discomfort — 29 reports (2.38%)
  10. Wrong Technique In Product Usage Process — 29 reports (2.38%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Afrezza approved in United States?

Yes. FDA authorised it on 27 June 2014; FDA has authorised it.

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

MANNKIND holds the US marketing authorisation.