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Regulatory/FDA

Amgen Gets OPDP Untitled Letter for Claims about Neulasta Onpro vs. PFS Delivery

Amgen Gets OPDP Untitled Letter for Claims about Neulasta Onpro vs. PFS Delivery

July 26, 2021 – The FDA’s Office of Prescription Drug Promotion (OPDP) cited Amgen for making misleading claims that the delivery of its product Neulasta® through the Onpro® on-body injector is more effective than delivery through the pre-filled syringe (PFS) or is more effective than FDA-licensed biosimilars, which are only available through PFS. OPDP takes […]

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