The FDA announced approval of the first generic of Symbicort — budesonide and formoterol fumarate dihydrate — Inhalation Aerosol for the treatment of asthma and COPD, according to an agency press release.
The complex generic drug-device combination product is a metered-dose inhaler. The generic is approved for treatment of asthma in patients aged 6 years and older and for maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD, including chronic bronchitis and/or emphysema, according to the release. It should not be used to treat acute asthma