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The complex generic inhalation aerosol named Breyna was made in partnership with the CDMO Kindeva Drug Delivery.
March 16, 2022
By: Tim Wright
Editor-in-Chief, Contract Pharma
Viatris and Kindeva Drug Delivery have revealed that Mylan Pharmaceuticals, a Viatris subsidiary, has received approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Breyna (budesonide and formoterol fumarate dihydrate inhalation aerosol), the first approved generic version of AstraZeneca’s Symbicort. Breyna, a drug-device combination product, is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD) and will be available in 160 m...
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