|View printer-friendly version|
|April 20, 2017 8:42 a.m.|
|Teva Launches AirDuo™ RespiClick® and its Authorized Generic, Two Inhalers Containing Fluticasone Propionate and Salmeterol|
First and Only Generic Fluticasone Propionate and Salmeterol (ICS/LABA) Inhaler Available in the U.S.
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
About AirDuo™ RespiClick® (Fluticasone Propionate and Salmeterol) Inhalation Powder and authorized generic fluticasone propionate and salmeterol inhalation powder (multidose dry powder inhaler)
The following Indication and Important Safety Information are applicable to both AirDuo RespiClick and its authorized generic.
AirDuo™ RespiClick® is indicated for the treatment of asthma in patients aged 12 years and older. AirDuo™ RespiClick® is only for patients uncontrolled on an ICS or whose disease severity clearly warrants an ICS/LABA.
Important Limitation of Use: AirDuo™ RespiClick® is NOT indicated for the relief of acute bronchospasm.
IMPORTANT SAFETY INFORMATION
WARNING: ASTHMA-RELATED DEATH
Please click here for full Prescribing Information, including Boxed WARNING:
About Teva Respiratory
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of AirDuo™ RespiClick® and its Authorized Generic, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
Teva Pharmaceutical Industries Ltd.