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# Nubeqa TV Ad, Video Misleading: FDA
- URL: https://www.fdaweb.com/nubeqa-tv-ad-video-misleading-fda/
- Published: 2026-04-30T12:00:00.000Z
- Updated: 2026-09-14T13:38:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161071

The CDER Office of Prescription Drug Promotion (OPDP) says a YouTube video and Spanish-language TV ad for Bayer’s Nubeqa (darolutamide) tablets for oral use are misleading because they include claims and representations about the drug’s benefits but omit important risk information associated with it. A 4/28 [Notice of Violation](https://www.fda.gov/media/192241/download?attachment&ref=fdaweb.com) says the ad and video fail to include material information from the labeling. “By omitting this important risk information, the video and TV ad fail to provide material information about the consequences that may result from the use of Nubeqa and create a misleading impression about the drug’s safety,” OPDP says.

In addition, the letter says, the major statements include presentations where the verbatim complete transcript or verbatim key terms or phrases from the corresponding audio do not appear in print on the screen. OPDP says the video and TV ad are also misleading because the “attention-grabbing visuals (e.g., vibrant colors, constant motion within the scenes, frame transitions, and camera movements) and frequent scene changes during the presentation of the major statement interfere with comprehension of the major statement.”

Bayer was told to respond with a list of all Nubeqa promotional communications that contain representations similar to those described in the Notice of Violations and a plan for discontinuing the communications or ceasing distribution of Nubeqa.