Teva digital asthma inhaler wins FDA nod


The ArmonAir Digihaler is for the treatment of asthma in patients 12 years and older.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) announced today that the US Food and Drug Administration (FDA) has approved ArmonAir Digihaler (fluticasone propionate). ArmonAir Digihaler dispenses inhalation powder, an inhaled corticosteroid (ICS), delivered via Teva’s Digihaler device, which contains built-in sensors and connects to a companion mobile application that provides information on inhaler use to people with asthma.

ArmonAir Digihaler is for the treatment of asthma in patients 12 years and older. ArmonAir® Digihaler™ is not indicated for the relief of acute bronchospasm.

ArmonAir Digihaler joins the approved Digihaler portfolio of products, including ProAir Digihaler (albuterol sulfate 117 mcg) Inhalation Powder, for use in patients 4 years of age and older to treat or prevent bronchospasm in those who have reversible obstructive airway disease and to prevent exercise-induced bronchospasm, and AirDuo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder, which for the treatment of asthma in patients 12 years of age and older.

The Digihaler device detects when the inhaler is used and measures inspiratory flow rates. These data are then sent to a companion mobile app using Bluetooth® Wireless Technology so that patients can review their data over time, and if desired, share it with their healthcare providers to have more informed discussions about their condition and treatment. Patients also can schedule reminders on their smartphone to take either their ArmonAir Digihaler or AirDuo Digihaler as prescribed.

Teva EVP global marketing and portfolio Sven Dethlefs said, "The approval of a third product in the Digihaler portfolio is an incredibly exciting milestone for us. Our portfolio now includes a rescue treatment, a maintenance combination therapy, and now a maintenance monotherapy. All three of these digital inhalers with built-in sensors pair with companion mobile apps, allowing patients to track their inhaler use across multiple digital devices and have a better understanding of their condition. Patients may also choose to share this data with their healthcare providers."

Published by Globes, Israel business news - - on February 24, 2020

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