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|June 28, 2016 8:00 a.m.|
|Teva Announces FDA Acceptance of New Drug Applications for Fluticasone Propionate/Salmeterol and Fluticasone Propionate RespiClick® Inhalers|
Therapies Utilize Core Multi-Dose Dry Powder Inhaler Technology that
“The FDA acceptance of these two filings represents an exciting time for
Teva’s specialty respiratory medicines business as we integrate both
fixed dose combination and monotherapy into our core, breath-actuated
RespiClick device,” said
The NDAs for fluticasone propionate/salmeterol RespiClick and fluticasone propionate RespiClick are supported by data from Teva’s clinical development program, including data from three Phase III trials which evaluated the efficacy and safety of the treatments in adolescent and adult patients with asthma. In the double-blind studies, both therapies showed clinically relevant and greater benefit compared with placebo in the improvement of lung function as measured by Forced Expiratory Volume in one second (FEV1). Safety profiles for fluticasone propionate/salmeterol RespiClick and fluticasone propionate RespiClick were found to be generally comparable to placebo and the majority of adverse events were mild to moderate in severity. In clinical trials for fluticasone propionate/salmeterol RespiClick, the most common adverse reactions (incidence ≥3%) were nasopharyngitis, headache, cough, oral candidiasis and back pain. In fluticasone propionate RespiClick clinical trials, the most common adverse reactions (incidence ≥3%) were nasopharyngitis, headache, cough, oral candidiasis and upper respiratory tract infection.
The NDAs for fluticasone propionate/salmeterol RespiClick and
fluticasone propionate RespiClick have been accepted by the
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