The U.S. Food and Drug Administration today approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Mylan obtained approval to market its generic inhaler in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg.
“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,” said Anna Abram, FDA’s Deputy Commissioner for Policy, Planning, Legislation and Analysis. “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.”
Inhalers are known as “combination products” because they consist of a drug and a device. The development of generic combination products can be more challenging than, for instance, solid oral dosage forms, like tablets, and the FDA regularly takes steps to help guide industry through the process. The FDA recognizes the 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.
Under GDUFA II, individual companies can meet with the FDA as part of their pre-ANDA program to support their development of such complex products. The FDA also publishes publicly available guidance documents describing the steps the FDA recommends companies take to submit complete, approvable applications for various types of drug products.