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Breztri fda approval?

See the DrugPatentWatch profile for Breztri

When did Breztri get FDA approval?

Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) was approved by the FDA on November 5, 2019 for the treatment of chronic obstructive pulmonary disease (COPD). [1]

What is Breztri FDA-approved to treat?

The FDA-approved indication for Breztri is maintenance treatment of COPD in patients who are not adequately treated by other maintenance therapies. [1]

Who makes Breztri, and what type of product is it?

Breztri is made by AstraZeneca and is an inhaled triple-therapy combination (an inhaled corticosteroid plus a long-acting muscarinic antagonist plus a long-acting beta2-agonist) delivered via Aerosphere inhaler. [1]

Where can I verify the FDA approval details?

You can verify the approval information on the FDA approval record page for Breztri. [1]
For patent/exclusivity and related commercial details, DrugPatentWatch tracks the drug’s IP landscape as well. [2]

Sources:
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208586
[2] https://www.drugpatentwatch.com/



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