Complete Response Letters
AstraZeneca AB: Breztri Aerosphere
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Sep 30, 2019
Food, Drug, and Cosmetic Act for Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate) 160/9/4.8 mcg Inhalation Aerosol.
CRL_NDA212122_20190930:p1:s13The submitted data do not provide substantial evidence of the efficacy and safety for the use of Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate)
CRL_NDA212122_20190930:p1:s17Therefore, the submitted data do not establish the contribution of budesonide to the Breztri Aerosphere combination product.
CRL_NDA212122_20190930:p1:s20Moreover, as only a single Breztri Aerosphere phase 3 pivotal trial was submitted with this application, there was no additional data to directly support the efficacy and safety of Breztri Aerosphere.
CRL_NDA212122_20190930:p1:s22In order to address the above deficiency, conduct an additional trial or trials to provide data to demonstrate the efficacy of the Breztri Aerosphere combination product and the contribution of budesonide to the combination product.
CRL_NDA212122_20190930:p1:s26More Complete Response Letters
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