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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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FDA Approves Symbicort Asthma Combo Therapy

FDA approved AstraZeneca's asthma therapy Symbicort (budesonide/formoterol) July 21 for patients 12 and older after a standard 10-month review

FDA Approves Symbicort Asthma Combo Therapy

FDA approved AstraZeneca's asthma therapy Symbicort (budesonide/formoterol) July 21 for patients 12 and older after a standard 10-month review

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.

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