The U.S. FDA has approved Mylan’s Breyna®, a generic for AstraZeneca’s Symbicort® (budesonide/formoterol fumarate dihydrate) inhalation aerosol. Brand name Symbicort first received FDA approval in 2006, and an authorized generic from Prasco launched in 2020.
- The first AB-rated generic for Symbicort, Breyna is indicated to provide:
- Asthma treatment for patients at least six years of
- Maintenance treatment for airflow obstruction and to reduce exacerbations for patients who have chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
- Recommended dosing is as follows:
- Asthma (patients at least 12 years old): Two inhalations twice daily of either 80mcg budesonide/4.5mcg formoterol or 160mcg budesonide/4.5mcg formoterol. The starting dosage strength is based on asthma severity.
- Asthma (patients six to less than 12 years old): Two 80mcg/4.5mcg inhalations twice
- COPD: Two 160mcg/4.5mcg inhalations twice
- Mylan hopes to launch Breyna in 2022, depending on the outcome of patent litigation. Pricing information is not yet available.
