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Airsupra FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 13, 2023.

FDA Approved: Yes (First approved January 10, 2023)
Brand name: Airsupra
Generic name: albuterol and budesonide
Dosage form: Inhalation Aerosol
Company: AstraZeneca
Treatment for: Asthma

Airsupra (albuterol and budesonide) is a beta2-adrenergic agonist and corticosteroid fixed-dose combination rescue inhaler for as-needed use to reduce the risk of asthma exacerbations.

Development timeline for Airsupra

Jan 11, 2023Approval FDA Approves Airsupra (albuterol/budesonide) Metered-Dose Inhaler to Reduce the Risk of Asthma Exacerbations
Nov  9, 2022PT027 Recommended by FDA Advisory Committee as New Rescue Treatment for Asthma
May 15, 2022PT027, a Novel Fixed-Dose Combination of Albuterol and Budesonide Used as Rescue Medicine Significantly Reduced the Risk of a Severe Exacerbation Compared to Albuterol by 27% in Patients with Asthma
Sep  9, 2021Fixed-Dose Combination of Albuterol and Budesonide (PT027) Demonstrated Significant Benefits for Asthma Patients in MANDALA and DENALI Phase III Trials

Further information

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