Viatris and Kindeva Drug Delivery have launched Breyna (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol to treat certain asthma and chronic obstructive pulmonary disease (COPD) patients.
The drug-device combination product, Breyna is claimed to be the first US Food and Drug Administration (FDA)-approved generic version of AstraZeneca’s Symbicort.
It will be immediately available in 160 mcg/4.5 mcg and 80 mcg/4.5 mcg doses.
The therapy is indicated for the treatment of asthma patients aged six years and above.
It is also indicated as the maintenance treatment of airflow obstruction and to reduce exacerbations in COPD patients, including chronic bronchitis and/or emphysema.
Viatris noted that the 160 mcg/4.5 mcg dose of Breyna is only indicated for COPD treatment.
Viatris North America head Jose Cotarelo said: “We are excited to bring Breyna to the U.S. market for the many Americans living with asthma and COPD.
“Being the first to bring an FDA-approved generic version of Symbicort to patients is a true example of how access is the cornerstone of our mission to empower people worldwide to live healthier at every stage of life.”
According to the company, over 16 million Americans are affected by COPD and nearly 25 million have asthma.
Kindeva Drug Delivery CEO Milton Boyer said: “The launch of Breyna represents a significant milestone as it is the first FDA-approved generic version of Symbicort in the U.S., one of the most prescribed complex drug-device combination products to treat asthma and COPD.”