FDA Approves First Generic of Symbicort for Asthma and COPD

The US Food and Drug Administration (FDA) approved the first generic of budesonide and formoterol fumarate dihydrate (Symbicort) Inhalation Aerosol for asthma in patients 6 years and older and for the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

The FDA granted approval of this generic budesonide and formoterol fumarate dihydrate inhalation aerosol to Mylan Pharmaceuticals, Inc.

The inhaler was not indicated for the treatment of acute asthma attacks.

The drug-device combination product is a metered-dose inhaler (MDI) consisting of budesonide and formoterol that requires 2 inhalations twice a day at roughly 12 hours apart. It can be used for both disease to prevent symptoms including wheezing and help patients with breathing, especially for those with COPD.

The inhaler is approved for 2 strengths, 160/4.5 mcg/actuation and 80/4.5 mcg/actuation.

"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."