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FDA approves Teva’s digital COPD, asthma inhaler

December 26, 2018 By Sarah Faulkner

Teva Pharmaceuticals - updated logoTeva (NYSE:TEVA) said this week that the FDA approved its ProAir Digihaler device – a digital inhaler that uses sensors to connect to a companion mobile app for people with asthma and chronic obstructive pulmonary disease.

The company’s device features built-in sensors that can measure inspiratory flow and detect when the inhaler is used. After the data is sent to a mobile app, the user can review historical data and share it with their healthcare professionals.

Teva’s ProAir Digihaler is indicated for the treatment or prevention of bronchospasm in people with reversible obstructive airway disease and for prevention of exercise-induced bronchospasm.

“This approval marks a significant milestone not only for Teva, but for the respiratory community as it allows patients and their caregivers to better understand inhaler usage through digital technology,” Sven Dethlefs, EVP of global marketing & portfolio at Teva, said in prepared remarks.

“Teva recognizes the importance of integrating technology into patient care, and we are very proud to lead the way with the approval of ProAir Digihaler. 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,” Dethlefs added.

“One of the challenges physicians are faced with in caring for their asthma and COPD patients is knowing if their patients are using their inhaled medication as they should. That’s what makes a product like this so important to doctor-patient discussions,” Dr. Tushar Shah, SVP of global specialty clinical development at Teva, said. “Offering a tool that enables doctors to see data on their patients’ inhaler usage will allow them to have more productive conversations about identifying issues and how to manage their illness.”

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Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Respiratory, Wall Street Beat Tagged With: Teva Pharmaceuticals

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