The FDA has approved Teva’s ArmonAir Digihaler fluticasone propionate DPI for the treatment of asthma in patients aged 12 and older, the company said. ArmonAir Respiclick was approved for that indication in January 2017. Three doses were approved for twice daily inhalation: 55 mcg, 113 mcg and 232 mcg.
The Digihaler device includes a built-in usage monitoring system and connects via Bluetooth to a mobile app. Teva’s ProAir albuterol Digihaler was approved by the FDA in December 2018, and the DuoAir fluticasone propionate/salmeterol Digihaler was approved in July 2019. According to the company, the full range of Digihaler products is expected to be available to US patients later in 2020.
Teva Executive VP, Global Marketing & Portfolio, Sven Dethlefs commented, “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.”
Read the Teva press release.
