Agency hopes green light for complex drug device combination improves competition and access more affordable medications.

The FDA has approved budesonide and formoterol fumarate dihydrate inhalation aerosol, a generic of Symbicort (AstraZeneca), for the treatment of 2 individuals aged 6 years or older with asthma and for the maintenance treatment of airflow instruction and reducing exacerbation for individuals with chronic obstructive pulmonary disease, (COPD), including chronic bronchitis and/or emphysema.1

“Today’s 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,” Sally Choe, PhD, director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research, said in a statement. Asthma is a chronic, long-term condition that affects the airways in the lungs and can worsen during physical activity. It often starts in adolescence.1

The generic drug device should not be used to treat acute asthma attacks, according to the FDA.1

The drug-device combination is a metered-dose inhaler that contains budesonide, which is a corticosteroid that reduces inflammation, and formoterol, which is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.1

Usually, 2 inhalations twice a day helps treat both diseases by preventing symptoms, such as wheezing, for those with asthma and by promoting better breathing for those with COPD. The inhaler is approved in 160/4.5-mcg/actuation and 80/4.5-mcg/actuation strengths.1

The most common adverse events (AEs) for individuals with asthma are headaches, nasopharyngitis, oral candidiasis, pharyngolaryngeal, stomach discomfort, upper-respiratory-tract infections, and vomiting.1

For those with COPD, the most common AEs are bronchitis, nasopharyngitis, oral candidiasis, sinusitis, and upper-respiratory-tract infections.1

In June 2015, the FDA published product-specific guidance for budesonide and formoterol fumarate dihydrate inhalation aerosol.1

They also require sponsors to submit appropriate data and information to demonstrate that complex generic drug combination products meet the agency’s approval standards.1

Complex products are medical products where possible alternative approaches to product development or uncertainty concerning approval pathway can benefit from early scientific engagement, according to the FDA.1

Furthermore, drug-device combinations are typically more challenging to develop, so few exist and results in less market competition.1

Approximately 25 million individuals are affected by asthma, including more than 5 million children, according to the National Heart, Lung, and Blood Institute.2

Asthma is a chronic, long-term condition that affects the airways in the lungs and can worsen during physical activity. It often starts in adolescence.2

The symptoms of asthma are coughing, shortness of breath, and wheezing.2

Meanwhile, COPD affects more than 16 million individuals. COPD, which encompasses emphysema and chronic bronchitis, is a long-term chronic disease that causes airflow blockage and makes it difficult to breathe.3


  1. FDA approves first generic of Symbicort to treat asthma and COPD. FDA. News release. March 15, 2022. Accessed March 16, 2022.
  2. National Heart, Lung, and Blood Institute. Asthma. Accessed March 16, 2022.
  3. National Heart, Lung, and Blood Institute. COPD. Accessed March 16, 2022.

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