FDA promotions watchdog delivers first warning letter of the year to AstraZeneca over Breztri marketing

15 Aug 2023
AstraZeneca has received the first warning letter of the year from the FDA’s promotion police over alleged efficacy claims for its COPD med Breztri Aerosphere. The warning is only the second letter of the year from FDA’s promo office, following an untitled letter in June to Xeris Pharmaceuticals for its Cushing’s syndrome drug Recorlev.
The Office of Prescription Drug Promotion (OPDP) sent the AstraZeneca warning letter – the more serious of the two types of enforcement notices – regarding a Breztri “professional sales aid” during the first week of August.
FDA promotions watchdog delivers first warning letter of the year to AstraZeneca over Breztri marketing
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Source: EndPoints
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