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# False, Misleading Claims in Neulasta Professional Animated Banner: OPDP
- URL: https://www.fdaweb.com/false-misleading-claims-in-neulasta-professional-animated-banner-opdp/
- Published: 2021-07-14T12:00:00.000Z
- Updated: 2026-09-14T17:06:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149706

The CDER Office of Prescription Drug Promotion (OPDP) says a professional animated banner for Amgen’s Neulasta (pegfilgrastim) injection for subcutaneous use makes false or misleading claims and representations about the drug’s benefits and thus misbrands it. A 7/7 [Notice of Violation](https://www.fda.gov/media/150751/download?ref=fdaweb.com) says the FDA Bad Ad Program received complaints about promotional communications with similar claims and presentations as the ones discussed in the letter.

“These violations are concerning from a public health perspective because this promotional communication’s misleading claims could cause healthcare providers to conclude that Neulasta delivered via the Onpro on-body injector is more effective than Neulasta delivered via prefilled syringe or that it is more effective than FDA-licensed biosimilar pegfilgrastim products, which are only delivered via prefilled syringe,” OPDP says.

Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant increase of febrile neutropenia. The labeling includes Contraindications and Warnings and Precautions.

The letter says the banner claims state there is a statistically significant higher risk of febrile neutropenia when pegfilgrastim is administered via a prefilled syringe compared to the Onpro on-body injector. “However,” OPDP says, “the multiple limitations of the cited study preclude the drawing of such conclusions regarding the comparative risk of febrile neutropenia in patients taking pegfilgrastim depending on delivery method.”

Amgen was told to reply with a list of all its promotional communications for Neulasta that contain representations like those cited in the letter and explaining its plan for discontinuing the use of such communications or for ceasing distribution of Neulasta.