AstraZeneca Files NDA For Symbicort Asthma Therapy
This article was originally published in The Pink Sheet Daily
Executive Summary
Company has discussed potential delays in review of the metered dose inhaler asthma product.
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Symbicort NDA On-Track Despite FDA Data Request, AstraZeneca Says
FDA has requested additional chemistry, manufacturing and control data for Symbicort inhalation delivery device. While AstraZeneca does not believe this will significantly delay product development, the company does have a back-up strategy for a slightly modified device.