FDA OKs First Generic Version of Advair Diskus

This article was originally published on Pharmacy Times.

The FDA has approved the first generic version of Advair Diskus (GlaxoSmithKline), a fluticasone propionate and salmeterol inhalation powder product. Approved for 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg doses, the generic drug (Wixela Inhub, Mylan) is indicated to treat patients with asthma and chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema.

The newly approved fluticasone propionate and salmeterol inhalation powder contains a corticosteroid and a long-acting beta(2)-adrenergic agonist (LABA) indicated for twice daily treatment of asthma in patients aged 4 years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD. This medicine is a complex drug-device combination product for which no generic product has been previously approved by FDA.

Generic drugs are approved once they have met FDA’s rigorous approval standards to ensure the generic drug is as safe and effective as the brand name drug product. The generic must also meet the same quality requirements for manufacturing and packaging as the brand name drug product. FDA expedited the review of this abbreviated new drug application (ANDA) as a potential first generic.

In the United States, 26 million people, including children, have asthma and 16 million people are living with COPD. According to the FDA, today’s approval should provide greater patient access to this medication.

Reference

FDA approves first generic Advair Diskus [news release]. Silver Spring, MD; January 30, 2019: FDA website. https://bit.ly/2DK6uhG. Accessed January 30, 2019