FDA — authorised 10 January 2023
- Application: NDA214070
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: AIRSUPRA
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
🇺🇸 Airsupra in United States
FDA authorised Airsupra on 10 January 2023 · 1,300 US adverse-event reports
Marketing authorisations
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.
- Window: 28 March 2025 – 28 March 2026
- Total reports: 1,300
Most-reported reactions
- Device Delivery System Issue — 290 reports (22.31%)
- Product Dose Omission Issue — 148 reports (11.38%)
- Asthma — 142 reports (10.92%)
- Wrong Technique In Device Usage Process — 131 reports (10.08%)
- Dyspnoea — 113 reports (8.69%)
- Wrong Technique In Product Usage Process — 105 reports (8.08%)
- Device Use Issue — 96 reports (7.38%)
- Drug Ineffective — 96 reports (7.38%)
- Incorrect Dose Administered By Device — 93 reports (7.15%)
- Device Malfunction — 86 reports (6.62%)
Other Other approved in United States
Frequently asked questions
Is Airsupra approved in United States?
Yes. FDA authorised it on 10 January 2023; FDA has authorised it.
Who is the marketing authorisation holder for Airsupra in United States?
ASTRAZENECA holds the US marketing authorisation.