AirDuo Digihaler to treat asthma receives FDA nodSeptember 6, 2019
Teva said its AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) inhalation powder, has been granted approval by the US.
The digital inhaler has built-in sensors that connect to a companion mobile application to provide information on inhaler use to people with asthma.
AirDuo Digihaler is indicated for the treatment of asthma in patients aged 12 years and older.
The approval of AirDuo Digihaler is based on the review of the supplemental new drug application (sNDA) submitted by Teva to the FDA.
AirDuo Digihaler was approved in a low, medium and high dose: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily.
As a fixed-dose combination asthma therapy containing an ICS and a LABA, AirDuo Digihaler contains the same active ingredients as Advair Diskus, which is also approved in low, medium and high doses: 100/50 mcg, 250/50 mcg and 500/50 mcg, Teva said.