FDA approves Symbicort to treat asthma and COPD
pharmafile | March 16, 2022 | News story | Research and Development |
The FDA has approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for the treatment of asthma in patients six years and older, and chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Asthma impacts 25 million people, more than five million of whom are children, while COPD affects over 16 million, according to the National Heart, Lung, and Blood Institute.
This generic drug-device combination product, which is a metered dose inhaler, should not be used to treat acute asthma attacks.
“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. “This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.”
This product is a metered-dose inhaler (MDI), containing 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).
Lina Adams
