FDA Approves First Digital Inhaler With Tracking App

SOMEONE SOMEWHERE

The US Food and Drug Administration (FDA) has approved the first and only digital inhaler with a built-in sensor that connects to a companion mobile application that can monitor usage as well as strength of the user’s inhalation.

The ProAir Digihaler, from Teva Pharmaceutical Industries, contains albuterol sulfate 117 µg powder for inhalation.

The new inhaler is approved for use in people aged 4 years and older to treat or prevent bronchospasm in individuals with reversible obstructive airway disease and to prevent exercise-induced bronchospasm. The approval is based on review of a supplemental new drug application submitted by Teva to the FDA.

“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 [chronic obstructive pulmonary disease] management,” Sven Dethlefs, Teva executive vice president, global marketing…

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