Teva announced that the Food and Drug Administration (FDA) has approved ProAir Digihaler (albuterol sulfate) inhalation powder for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older. The approval was based on the review of a supplemental New Drug Application (sNDA). 

ProAir Digihaler is the first digital inhaler with built-in sensors that connects to a mobile application and provides data on inhaler use to patients with asthma and chronic obstructive pulmonary disease (COPD). The product combines a breath-activated, multi-dose dry powder inhaler with albuterol along with a built-in electronic module and a companion app. The sensors detect and record when the inhaler is used and measure inspiratory flow; this data is then sent to the companion application via Bluetooth Wireless Technology so patients can review their data and share it with their healthcare professionals. 

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“The digital technology built into ProAir®Digihaler™ provides patients with data on their inhaler use, which may help them to have a more informed dialogue with their healthcare provider regarding their asthma or COPD management,” stated Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio. 

ProAir Digihaler will be supplied as a breath-actuated dry powder inhaler that meters 117mcg of albuterol sulfate from the device reservoir (108mcg from the mouthpiece) per actuation; the inhaler contains 200 actuations. It will be available in 2019 through several “Early Experience” Programs in order to compile real-world data. A national commercial launch is anticipated in 2020. 

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