Teva announced the simultaneous launch of AirDuo RespiClick (fluticasone propionate and salmeterol) inhalation powder and its authorized generic for the treatment of asthma in patients aged 12 years and older who are uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants the use of an ICS/long-acting beta2-adrenergic agonist (LABA) combination.
AirDuo RespiClick and its authorized generic are fixed-dose combination asthma therapies containing an ICS and a LABA, the same active ingredients as Advair. The authorized generic is known as fluticasone propionate and salmeterol inhalation powder (multidose dry powder inhaler). Teva is launching both products at the same time in an effort to address the need for more affordable asthma treatment options in the U.S. Teva expects that sales of the authorized generic will represent most of the sales of the two products.
“With the launch of AirDuo RespiClick and its authorized generic, our intent is to meet the needs of patients, providers, and payers in the U.S. seeking greater access to lower-cost asthma inhaler technology, while also allowing Teva to compete in the highly competitive asthma combination controller market,” said Rob Koremans, M.D., President and CEO of Global Specialty Medicines at Teva. “This important launch marks not only the first available generic ICS/LABA product in the U.S., but also the continued expansion of our RespiClick family of products, which now includes breath-activated inhaler options for both maintenance treatment and rescue medication.”
AirDuo RespiClick was approved by the U.S. Food and Drug Administration (FDA) in January 2017 in three doses: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily. AirDuo RespiClick contains medication 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.
Filed Under: Drug Discovery
