AstraZeneca Gets Rare Warning Letter Over Breztri Sales Aid; Footnotes Don’t Balance Graphics

Warning letter is first issued by US FDA’s Office of Prescription Drug Promotion in more than a year and only the seventh since March 2020, continuing a trend away from using the enforcement tool. AstraZeneca asked to distribute corrective communications about pamphlet’s efficacy claims.

Breztri warning letter
OPDP breathes fire on multiple claims in AstraZeneca's sales aid for the COPD treatment Breztri. • Source: Nielsen Hobbs; the Pink Sheet | images from Shutterstock, FDA

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