EO: Sec. 7. Access to Affordable Life-Saving Medications. Within 90 days of the date of this order, as appropriate and consistent with applicable law, the Secretary shall take action to ensure future grants available under section 330(e) of the Public Health Service Act,…
FDA Approval of First and Only Digital Inhaler with Built-In Sensors
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 reversable 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, Teva Pharmaceuticals, 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.
