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.
- Airsupra is indicated for the as-needed treatment or prevention of bronchoconstriction, and to reduce the risk of exacerbations in patients with asthma who are 18 years of age and older.
- Airsupra is a fixed-dose combination of the approved drugs albuterol and budesonide. Albuterol is a short-acting selective beta2-adrenergic agonist that works to relax the smooth muscles of the airways. Budesonide is a corticosteroid that reduces inflammation.
- Airsupra is a rescue inhaler intended to reduce the risk of asthma exacerbations. Current albuterol rescue inhalers work to alleviate acute asthma symptoms, but do not treat the underlying inflammation, leaving patients at risk of further exacerbations. Airsupra is a rescue treatment that allows patients to manage both their symptoms, and the inflammation associated with asthma.
- Airsupra is administered by oral inhalation as needed for asthma symptoms. No more than 6 doses (12 inhalations) should be administered in a 24-hour period.
- Warnings and precautions associated with Airsupra include cardiovascular effects, hypersensitivity reactions, hypokalemia, potential worsening of infections, oropharyngeal candidiasis, and ocular symptoms such as glaucoma and cataracts.
- Common adverse reactions include headache, oral candidiasis, cough, and dysphonia.
Development timeline for Airsupra
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
