Viatris (Nasdaq:VTRS) and Kindeva Drug Delivery announced today that the FDA approved its generic version of AstraZeneca’s Symbicort.
In March 2021, the FDA granted tentative approval to Breyna (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol) — the first generic version of Symbicort. Today, the agency granted approval for the abbreviated new drug application (ANDA) for the drug-device combination product for certain patients with asthma or chronic obstructive pulmonary disease (COPD).
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