On March 15, 2022, the FDA approved the first generic version of AstraZeneca’s Symbicort (budesonide and formoterol fumarate dihydrate), a blockbuster drug-device combination product to treat Asthma and COPD (Chronic Obstructive Pulmonary Disease).
Asthma is a chronic, and long-term complication that is known for affecting the airways in the lungs, which can be worsened by physical activity and most often occurs during childhood. It can be responsible for causing wheezing (a kind of whistling sound when breathing), coughing, and shortness of breath. Chronic Obstructive Pulmonary Disease, which mainly includes emphysema and chronic bronchitis, is a long-term, and chronic disease that is responsible for causing airflow blockage and makes it hard to breathe.
The approval of the first generic of Symbicort Inhalation Aerosol is for patients with asthma aged 6 years and older and for patients with COPD, including chronic bronchitis and/or emphysema. It is not for acute asthma attacks.
This complex drug-device combination product, which is a metered-dose inhaler (MDI) consisting of budesonide and formoterol that needs 2 inhalations twice daily (usually morning and night) at roughly 12 hours apart.
In MDI, budesonide specifically is a corticosteroid that is used for reducing the inflammation and formoterol is a long-acting bronchodilator that helps relax muscles in the airways in order to improve breathing.
It can be considered for both diseases for the prevention of symptoms including wheezing and help patients with breathing, typically for patients with chronic obstructive pulmonary disease.
This FDA approved inhaler is available for a couple of strengths, 160/4.5 mcg/actuation and 80/4.5 mcg/actuation.
According to Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, “This approval of the first generic for one of the most commonly prescribed complex drug-device combination products for the treatment of asthma and COPD is another step forward in our commitment to bring generic copies of complex medicines to the market, which can improve QoL and help reduce the cost of treatment. This reflects the FDA’s continued efforts to boost the competition and availability of Quality, Safe, Effective, and Affordable drugs for patients and consumers.”
The most commonly observed side effects due to budesonide and formoterol fumarate dihydrate oral inhalation aerosol for patients with asthma are headache, nasopharyngitis (swelling of nasal passages and back of throat), pharyngolaryngeal (nose and mouth) pain, upper respiratory tract infection, sinusitis, back pain, influenza, nasal congestion, vomiting, stomach discomfort, and oral candidiasis (thrush). For patients with COPD, the most commonly noted side effects are bronchitis, upper respiratory tract infection, nasopharyngitis, oral candidiasis, and sinusitis.