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Latest From CooperSurgical Inc.
Eton Pharmaceuticals gets untitled letter for promotion of its Alkindi Sprinkle hydrocortisone granules for treatment of pediatric adrenal insufficiency. The agency sent two letters last year objecting to sponsored links after a decade pause.
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.
US FDA's staff have sometimes worked late into the night to help sponsors meet deadlines and avoid errors in responding to a notice of violation. As is often the case, early communication helps avoid problems.
Agency cites video promoting Biohaven’s Nurtec ODT, which first aired on ABC’s TV show The View, for misleading comparative claims, inadequate display of risk information, and failure to submit promo for review.
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