FDA approves 1st generic version of common asthma, COPD drug

The FDA on March 15 approved the first generic version of Symbicort inhalation aerosol to treat asthma and chronic obstructive pulmonary disease. 

The generic drug-device combination product is a metered-dose inhaler that contains budesonide and formoterol. It was approved for patients six years and older to prevent symptoms and should not be used to treat acute asthma exacerbations, the FDA 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," said Sally Choe, PhD, director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research.

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