Abstract
Wixela® Inhub® is the first therapeutically equivalent, substitutable generic version of Advair Diskus® (fluticasone propionate/salmeterol) approved for the treatment of asthma and chronic obstructive pulmonary disease (COPD) in the USA. Wixela Inhub combines the inhaled corticosteroid fluticasone propionate and the long-acting β2-adrenoceptor agonist salmeterol in a single dry-powder inhaler. Each drug has a different mechanism of action, targeting different and complementary aspects of the pathophysiology of asthma and COPD. The in vitro performance of Wixela Inhub is comparable to that of Advair Diskus at all dosage strengths (100/50 μg, 250/50 μg, and 500/50 μg) and all flow rates. Wixela Inhub has pharmacokinetic and pulmonary therapeutic bioequivalence to Advair Diskus, which has well-established efficacy, tolerability, and safety profiles. The Wixela Inhub device is robust and easy to use without instruction. All three dosage strengths of Wixela Inhub will be offered at a wholesale acquisition cost of up to 70% less than Advair Diskus and the authorized generic equivalent.
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