FDA approves new Breztri Aerosphere application from AstraZeneca
The FDA approved a Type 5 new formulation or manufacturer submission for Breztri Aerosphere on October 8, 2026.
The U.S. Food and Drug Administration approved a new application for Breztri Aerosphere, submitted by AstraZeneca AB, with a submission status date of October 8, 2026. The application is listed as NDA220290, original submission 1, and its status is recorded as approved.1
The filing is classified as a Type 5 submission, covering a new formulation or new manufacturer, and was reviewed under standard priority.1
Breztri Aerosphere is formulated as an inhalant for oral route administration. The product combines budesonide, glycopyrrolate, and formoterol fumarate at a strength of 160 micrograms per 9 micrograms per 4.8 micrograms.1
The FDA's approval letter for this submission is dated October 9, 2026, and is available on the agency's Drugs@FDA database.1
The record does not specify the clinical basis for this particular submission beyond its classification as a new formulation or manufacturer change, nor does it detail any label changes associated with the approval.
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