FDA Gives Thumbs Down To Amgen’s Film Noir Aranesp Promo
This article was originally published in The Pink Sheet Daily
Amgen’s direct mailer featuring the image of a man in free fall misleading suggests Aranesp is useful in a broader patient population than it is indicated for, agency says.
You may also be interested in...
Animated banner ad claiming administration of Neulasta with Amgen’s Onpro on-body injector has less risk of febrile neutropenia than administration via prefilled syringe draws untitled letter and a rare press release. FDA says claims could undermine confidence in biosimilar pegfilgrastim products.
OPDP Director Tom Abrams cautions against reading into the “snapshot.”
Amgen pled guilty to marketing Aranesp off-label as part of a global settlement with the government; the final agreement, expected to be approved on Dec. 19, could involve marketing practices of Enbrel and six other drugs.