Medication Monitor

Generic Name (Trade Name—Company)
December 27, 2018

Albuterol sulfate 117 mcg digital inhaler

(ProAir Digihaler—Teva)
Teva announces FDA approval of digital inhaler with built-in sensors

Teva announced FDA approval of albuterol sulfate 117 mcg digital inhaler for treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm in patients aged 4 years and older.

The inhaler combines a breath-activated, multidose dry powder inhaler with albuterol, the most widely used asthma rescue medication, with a built-in electronic module and a companion mobile app. The built-in sensors detect when the inhaler is used and measure inspiratory flow, then send data to the companion mobile app so patients can review their data over time and, if desired, share it with their health professionals.

The inhaler will be available in 2019 through a small number of “Early Experience” Programs, which will be conducted in partnership with health care systems and in limited geographies in order to gather real-world experience. A national launch is planned for 2020. For more information, visit