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July 1, 2021ArmonAir RespiClick Now Indicated for Broader Pediatric Use
July 1, 2021 – The U.S. FDA has approved an expanded indication for ArmonAirTM RespiClick® (fluticasone propionate) oral inhalation powder, manufactured by Teva. The drug, which was previously approved for patients ages 12 years and up as prophylactic therapy for maintenance treatment of asthma, is now indicated for patients who are at least four years old.
A leading cause of missed school days, emergency room visits, and hospitalization in children, asthma is a chronic, inflammatory disease that can make it difficult to breathe. This can interfere with things like getting quality sleep, being able to play or exercise, and recovery from respiratory infections. Asthma can be inherited or acquired (for instance, due to exposure to cigarette smoke). Inhaled corticosteroids like ArmonAir Respiclick can help manage asthma by reducing inflammation.
The safety and efficacy of ArmonAir RespiClick was evaluated in a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 841 patients 4-11 years of age who had been diagnosed with persistent asthma. Recommended dosing for this age group is one 30mcg or 55mcg oral inhalation twice daily, depending on asthma severity and treatment history.
ArmonAir RespiClick first received FDA approval in 2017.