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# AstraZeneca Gets 1st OPDP 2023 Warning Letter
- URL: https://www.fdaweb.com/astrazeneca-gets-1st-opdp-2023-warning-letter/
- Published: 2023-08-15T12:00:00.000Z
- Updated: 2026-09-14T18:50:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155096

The CDER Office of Prescription Drug Promotion (OPDP) issued an 8/4 Warning Letter to AstraZeneca about a professional sales aid for its Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol for oral inhalation use. The [letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/astrazeneca-pharmaceuticals-lp-664789-08042023?ref=fdaweb.com) is the first Warning Letter issued by OPDP this year.

“The sales aid makes false or misleading claims and/or representations about the efficacy of Breztri,” OPDP says…. “These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the overall benefits a patient may expect as a result of Breztri treatment.”

The Breztri labeling says it is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). It is not indicated for the relief of acute bronchospasm or to treat asthma. The labeling contains several Warnings and Precautions, OPDP says.

The letter says a headline, graph, and claims in the promotional sales aid are misleading because they suggest that Breztri treatment has been shown to have a positive impact on all-cause mortality and to reduce the risk of death in COPD patients. “These suggestions are not supported by the cited references that analyzed data from the ETHOS trial,” it says.

Other claims in the sales aid suggest that the drug will have a statistically significant reduction in severe exacerbations, OPDP says. “This suggestion is not supported by the ETHOS trial data analyzed in the cited reference because the reduction in severe exacerbations was not statistically significant for patients treated with Breztri relative to comparator groups,” it says.

AstraZeneca was told to respond and address the concerns in the letter, listing all other Breztri promotional communications that contain representations such as those described in the Warning and explaining any plan for discontinuing the use of such communications or for ceasing distribution of Breztri. The company was also told to include in its response a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communications about the concerns discussed in the letter to the audiences that received the sales aid.