PETAH TIKVA (dpa-AFX) - Teva Pharmaceutical Industries Ltd. (TEVA) announced the U.S. FDA has approved ProAir Digihaler inhalation powder, the first digital inhaler with built-in sensors which connects to a companion mobile application and provides inhaler use information to people with asthma and COPD. The inhaler-use data is sent to the companion mobile app using Bluetooth Wireless Technology. The approval is based on the review of a supplemental new drug application submitted by Teva to the FDA.
ProAir Digihaler is indicated for the treatment or prevention of bronchospasm in patients aged four years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm in patients aged four years and older.
Teva said the ProAir Digihaler will be available in 2019 through a small number of 'Early Experience' Programs. A national launch is planned for 2020.
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