First Generic Drug Approvals

First Generic Drug Approvals

The U.S. Food and Drug Administration (FDA) today approved the first generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder), 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg, an important treatment for patients living with asthma and chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema. In America, 26 million people, including millions of children, have asthma and 16 million people are living with COPD. Today’s approval should provide greater access to this medication for these patients.

The newly approved fluticasone propionate and salmeterol inhalation powder, USP (Wixela Inhub), 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.

More information about this approval can be found at Drugs@FDA. Visit the First Generic Drug Approvals page to view a full list of first generic drug approvals.