Viatris debuts Breyna, first FDA-approved Symbicort generic

1 August 2023

USA-based generics major Viatris (Nasdaq: VTRS) and Kindeva Drug Delivery today announced the launch of Breyna (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the first generic version of AstraZeneca's (LSE: AZN) Symbicort with an Abbreviated New Drug Application (ANDA) approved by the US Food and Drug Administration (FDA).

Breyna, a drug-device combination product, is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD) and will be immediately available in both 80mcg/4.5mcg and 160mcg/4.5mcg dosage strengths.

In January 2022, AstraZeneca itself launched an authorized of Symbicort, a brand that brought in $2.5 billion sales for the UK pharma major in 2022,

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