Viatris and Kindeva Drug Delivery have announced the launch of Breyna budesonide / formoterol fumarate MDI, a generic version of AstraZeneca’s Symbicort, for the treatment of asthma in patients aged 6 and over and for the treatment of COPD. The FDA tentatively approved Breyna in March 2021 and issued a final approval in March 2022 amid patent litigation from AstraZeneca. According to Viatris, Breyna is available immediately in both dosage levels.
Viatris Head of North America Jose Cotarelo commented, “We are excited to bring Breyna to the US market for the many Americans living with asthma and COPD. This launch represents years of hard work breaking down barriers to access and builds upon our past successes of bringing other complex products to market as we continue to move up the value chain. 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.”
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 US, one of the most prescribed complex drug-device combination products to treat asthma and COPD. We are pleased for Viatris as well as the many Kindeva colleagues who have worked tirelessly to leverage our complex drug-delivery expertise for this important respiratory product — supporting a persistent need to continue bringing more quality medicines for asthma and COPD to patients.”
Read the Viatris press release.
