First Generic Version of Advair Diskus Gets FDA Approval

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Like other inhalers, the product is classified by the FDA as a drug-device combination.
Like other inhalers, the product is classified by the FDA as a drug-device combination.

The Food and Drug Administration (FDA) has approved Mylan's Wixela Inhub, the first generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder; GlaxoSmithKline) for the treatment of asthma in patients aged 4 years and older and for the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). 

Wixela Inhub combines fluticasone propionate, a synthetic corticosteroid, and salmeterol, a long-acting beta2-adrenergic agonist (LABA). The efficacy of Wixela Inhub was found to be equivalent to Advair Diskus in a 28-day, randomized, double-blind, placebo-controlled, parallel group study involving 1,128 adult asthma patients.

Like other inhalers, Wixela Inhub is classified by the FDA as a drug-device combination.Commenting on the approval, Anna Abram, the FDA's Deputy Commissioner for Policy, Planning, Legislation and Analysis said "The FDA recognizes challenges companies face when seeking to develop hard-to-copy complex generics, such as drug-device combination products, including when the drugs are incorporated into inhalation devices like this. We are committed to advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we're prioritizing review of many applications covering proposed generic complex products for which a generic has not yet been approved."

Mylan plans to make Wixela Inhub available in 3 strengths: 100mcg/50mcg, 250mcg/50mcg, and 500mcg/50mcg. The product is expected to be available in the second half of February 2019. 

For more information call (800) 796-9526 or visit Mylan.com.

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