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

 
• By Derrick Gingery

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

Footnotes and statements below graphics cannot absolve the problems raised by misleading claims in an promotional piece, the US Food and Drug Administration told AstraZeneca PLC in a rare warning letter.

The agency’s Office of Prescription Drug Promotion cited an AstraZeneca sales aid for its chronic obstructive pulmonary disease treatment Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate). The

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