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ProAir Digihaler FDA Approval History

Last updated by Judith Stewart, BPharm on May 2, 2024.

FDA Approved: Yes (Discontinued) (First approved December 21, 2018)
Brand name: ProAir Digihaler
Generic name: albuterol sulfate
Dosage form: Inhalation Powder
Company: Teva Pharmaceuticals USA, Inc.
Treatment for: Bronchospasm Prophylaxis, Asthma, COPD

ProAir Digihaler (albuterol sulfate) is a beta2-adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, and the prevention of exercise-induced bronchospasm.

The digital inhalers from Teva Pharmaceuticals (ProAir Digihaler, ArmonAir Digihaler, and AirDuo Digihaler) will be discontinued from June 1, 2024. Asthma patients who use a Digihaler device should talk with their doctor about alternatives.

ProAir Digihaler is a digital inhaler with built-in sensors that detect how often the inhaler is used, and measure respiratory flow. The inhaler use data is sent to the companion mobile app using Bluetooth® wireless technology so patients can review their data over time and share the reports with their caregivers and healthcare professionals if needed. ProAir Digihaler does not need to be connected to the app in order to take the medicine, and the electronic module does not control or interfere with delivery of the medicine through the inhaler.

IMPORTANT SAFETY INFORMATION

Development timeline for ProAir Digihaler

DateArticle
Dec 21, 2018Approval FDA Approves ProAir Digihaler (albuterol sulfate) as the First and Only Digital Inhaler with Built-In Sensors

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.