FDA approves first generic of Symbicort to treat asthma and COPD

The US Food and Drug Administration (FDA) approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol by Mylan Pharma for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and/or emphysema.

In a statement, FDA said that this drug-device combination product is a Metered-Dose Inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). Two inhalations, two times a day (usually morning and night, about 12 hours apart), treat both diseases by preventing symptoms, such as wheezing for those with asthma, and by helping with better breathing, for those with COPD. The inhaler is approved for two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation).

This approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment…….,” said Sally Choe, PhD, Director, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), FDA, in the statement.

It also said that the most common side effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol for those with asthma are nasopharyngitis (swelling of nasal passages and back of throat), headache, upper respiratory tract infection, pharyngolaryngeal (nose and mouth) pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting and oral candidiasis (thrush). For those with COPD, the most common side effects are nasopharyngitis, oral candidiasis, bronchitis, sinusitis and upper respiratory tract infection.