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FDA approves first Symbicort generic drug for asthma and COPD

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Posted at 9:17 PM, Mar 15, 2022

The U.S. Food and Drug Administration on Tuesday approved the first generic Symbicort drug used to treat asthma and chronic obstructive pulmonary disease (COPD), which are two common pulmonary health conditions.

The drug is an inhalation aerosol that treats asthma in patients 6-years-old and up and will treat airflow obstructions and reduce exacerbations for those with COPD. The drug will also treat chronic bronchitis and emphysema.

Sally Choe, Ph.D., director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research said, “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.”

Choe said, “This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers."

According to the FDA, asthma affects 25 million people, with more than 5 million of those being children. COPD affects more than 16 million people.

The drug comes as a metered-dose inhaler.