First Generic Version of Symbicort Gets FDA Approval

The Food and Drug Administration (FDA) has approved Mylan’s Abbreviated New Drug Application (ANDA) for Breyna™ (budesonide and formoterol fumarate dihydrate inhalation aerosol), the first generic version of Symbicort^®.

Breyna is a metered-dose inhaler containing a combination of budesonide, a corticosteroid, and formoterol, a long-acting beta₂ adrenergic agonist. The drug-device combination product will be available in 160mcg/4.5mcg and 80mcg/4.5mcg dosage strengths.

Breyna is indicated for the treatment of asthma in patients 6 years of age and older; and for maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

“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.

Reference

1. FDA approves first generic of Symbicort to treat asthma and COPD. News release. US Food and Drug Administration. Accessed March 16, 2022. www.fda.gov/news-events/press-announcements/fda-approves-first-generic-symbicort-treat-asthma-and-copd
2. Viatris Inc. announces receipt of the first FDA approval for generic version of Symbicort^® inhalation aerosol, Breyna™ (budesonide and formoterol fumarate dihydrate inhalation aerosol), in partnership with Kindeva. News release. Viatris Inc. Accessed March 16, 2022. www.prnewswire.com/news-releases/viatris-inc-announces-receipt-of-the-first-fda-approval-for-generic-version-of-symbicort-inhalation-aerosol-breyna-budesonide-and-formoterol-fumarate-dihydrate-inhalation-aerosol-in-partnership-with-kindeva-301503954.html