The FDA’s Office of Prescription Drug Promotion reviewed promotional material about the drug and said it misrepresented its efficacy. The material stated Breztri Aerosphere saw a “difference observed in time to all-cause mortality (over 52 weeks),” but the FDA said this is misleading since no COPD medications have proven a positive result on all-cause mortality.
This misbranding is in violation of the Federal Food, Drug, and Cosmetic Act and “makes its distribution violative,” the warning letter said. The letter is dated Aug. 4 and was posted to the agency’s website on Aug. 15.
