Mylan Pharmaceuticals ULC Launches Wixela® Inhub® (fluticasone propionate and salmeterol inhalation powder, USP), the First Available Bioequivalent Alternative to ADVAIR® DISKUS® (fluticasone propionate and salmeterol inhalation powder) in Canada
Wixela Inhub is available in the 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths for asthma patients and the 250 mcg/50 mcg and 500 mcg/50 mcg strengths for COPD patients.
Mylan Canada Country Manager
The research and development program for Wixela Inhub compared all strengths of treatment to ADVAIR DISKUS in order to meet regulatory requirements of therapeutic equivalence for a substitutable generic. In the 28-day, randomized, double-blind, placebo-controlled, parallel group study of 1,122 adult asthma patients conducted to evaluate the local (lung) bioequivalence of Wixela Inhub 100 mcg/50 mcg and ADVAIR DISKUS 100 mcg/50 mcg, the two treatments produced equivalent efficacy. Both treatments were safe and well-tolerated with lower numbers of withdrawals due to asthma compared to the placebo group. The study included both naive and current users of ADVAIR DISKUS.
ADVAIR DISKUS had Canadian sales of
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