The US FDA approved the first Symbicort generic (budesonide and formoterol fumarate dihydrate) inhalation aerosol for the treatment of asthma and COPD. The Symbicort generic manufactured by Mylan Pharmaceuticals (part of Viatris) is approved to treat asthma in patients six years of age and older and for the maintenance treatment of airflow obstruction and reducing exacerbations for patients with COPD.

Symbicort was launched in 2000 by AstraZeneca to treat asthma and/or COPD, and is currently approved in approximately 120 countries, according to the company.

Mylan’s Symbicort generic is a drug-device combination product delivered via 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). 

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.

“Today’s approval of the first [Symbicort] 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 of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research. “This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.”

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