FDA approves Teva’s two new RespiClick maintenance inhalers to treat asthma
Teva Pharmaceutical Industries has secured approval from the US Food and Drug Administration (FDA) for its new RespiClick maintenance inhalers to treat adolescent and adult patients with asthma.
The FDA has approved AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) and ArmonAir RespiClick (fluticasone propionate inhalation powder), which can be delivered through the firm’s RespiClick breath-activated and multi-dose dry powder inhaler (MDPI).
AirDuo RespiClick is a fixed dose combination product that contains same active ingredients as Advair, while AirDuo RespiClick is a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated to treat asthma in patients aged 12 years and older.
ArmonAir RespiClick is an inhaled corticosteroid (ICS) that contains same active ingredient as Flovent. It can be used for the maintenance treatment of asthma as prophylactic therapy in patients 12 years and older.
Both products were approved in three strengths, including AirDuo RespiClick with 55/14 mcg, 113/14mcg and 232/14mcg. ArmonAir RespiClick has been approved with 55mcg, 113mcg, and 232 mcg strengths.
Teva global R&D president and chief scientific officer Dr Michael Hayden said: “As a company on the forefront of developing inhaler technologies for people living with asthma, we are very pleased to now have two additional RespiClick-delivered medicines approved for adolescent and adult patients in the U.S.
“The expansion of our breath-activated product portfolio underscores Teva’s commitment to developing medicines that truly meet the needs of patients living with asthma and other respiratory diseases.”