April 8, 2022
ArmonAir® Digihaler® (fluticasone propionate) has received an expanded indication to provide maintenance treatment (as prophylactic therapy) for asthma in patients who are at least four years old.
- First approved in 2020, ArmonAir Digihaler was initially indicated for patients at least 12 years The active pharmaceutical ingredient, fluticasone propionate, has been FDA approved since 1994.
- The FDA also approved a new ArmonAir Digihaler 30mcg dosage strength for the younger pediatric Recommended dosing under the expanded indication is determined by the patient’s age and severity of disease:
- Patients 12 years and older: One 55mcg, 113mcg, or 232mcg dose taken twice daily by oral inhalation.
- Patients 4-11 years old: One 30mcg or 55mcg dose taken twice daily by oral inhalation.