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.
Salmeterol powder“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.”
According to the National Heart, Lung, and Blood Institute, 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.
“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.
In 2013, the FDA issued a draft product specific guidance for proposed generic drug products referencing Advair Diskus, which, among
other things, provides bioequivalence recommendations, as well as
formulation and device considerations. Further, as with brand-name
drugs, the FDA inspects manufacturing and packaging facilities for
generic drugs to ensure that they are capable of consistently producing
quality products.
The FDA requires appropriate data and information to demonstrate that complex generic drug-device combination products meet the agency’s
rigorous approval standards to ensure quality drug products that are as
safe and effective as their brand name counterparts are available to
patients.
The most common side effects associated with fluticasone propionate and salmeterol inhalation powder for the treatment of asthma include
upper respiratory tract infection or inflammation, swelling in the back
of the throat (pharyngitis), hoarse voice or trouble speaking
(dysphonia), oral candidiasis, bronchitis, cough, headaches, nausea and
vomiting. For the treatment of COPD the most common side effects are
pneumonia, oral candidiasis, throat irritation, hoarse voice or trouble
speaking (dysphonia), viral respiratory infections, headaches and
musculoskeletal pain.
