Advair Diskus – a combination of fluticasone propionate and salmeterol inhalation powder – is approved by FDA 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.
“Today’s approval of the first generic drug product for one of the most commonly prescribed asthma and COPD inhalers in the U.S. is part of our longstanding commitment to advance access to lower cost, high quality generic alternatives,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.
Asthma is a chronic lung disease that inflames and narrows the airways.
Asthma causes recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath and coughing.
The coughing often occurs at night or early in the morning.
Asthma affects people of all ages, but it most often starts during childhood.
In the United States, more than 26 million people are known to have asthma, about seven million of these people are children.
COPD is a progressive lung disease that makes it hard to breathe and may become worse over time.
COPD can cause coughing that produces large amounts of mucus, wheezing, shortness of breath, chest tightness and other symptoms.
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.
Source: U.S. Food and Drug Administration.