Viatris Wins First US Symbicort Generic – Will It Launch At Risk?

Federal Circuit Recently Told AstraZeneca It Would Not Review Viatris Win

In the wake of a favorable US Court of Appeals for the Federal Circuit decision, Viatris has won FDA approval for the first generic Symbicort product. The ANDA sponsor’s management had recently declared itself “ready to launch if the opportunity presents itself in 2022.”

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The FDA had published guidance in June 2015 • Source: Shutterstock

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