The US FDA has approved Teva Pharmaceuticals‘ AirDuo RespiClick and ArmonAir RespiClick, according to the company. AirDuo (fluticasone propionate and salmeterol inhalation powder) provides the same active ingredients as GSK’s Advair, while ArmonAir (fluticasone propionate inhalation powder) provides the same active ingredients as GSK’s Flovent.
Teva’s AirDuo RespiClick is not directly substitutable for Advair and is only approved for asthma, while Advair is also widely used for COPD, according to Reuters.
The two medications are delivered via Teva’s RespiClick breath-activated, multi-dose dry powder inhaler (MDPI) which is used with other approved medicines in Teva’s respiratory product portfolio.
AirDuo RespiClick is a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for the treatment of asthma in patients aged 12 years and older.
ArmonAir RespiClick is an inhaled corticosteroid (ICS) indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years and older.
Both products have been approved in three strengths:
- The approved strengths of AirDuo RespiClick are: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily.
- The approved strengths of ArmonAir RespiClick are: 55 mcg, 113 mcg, and 232 mcg administered as one inhalation twice daily.
“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,” said Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva.
AirDuo and ArmonAir are expected to become available by prescription to patients in the US later this year.