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

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.

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