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# Zenrelia Promotions ‘False and Misleading’: FDA
- URL: https://www.fdaweb.com/zenrelia-promotions-false-and-misleading-fda/
- Published: 2025-03-12T12:00:00.000Z
- Updated: 2026-09-14T14:55:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158812

The FDA Center for Veterinary Medicine says its review of Web sites, a brochure, and a slide deck promoting Elanco Animal Health’s Zenrelia (ilunocitinib tablets) identified false or misleading claims or representations about the drug’s safety or effectiveness. A just-released 1/28 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/elanco-animal-health-695170-01282025?ref=fdaweb.com) says the violations, which misbrand the drug, are especially concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Zenrelia, which is a recently approved veterinary drug in the Janus Kinase inhibitor drug class.

The letter says Zenrelia is indicated to control pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

The labeling has a Boxed Warning on the risk of fatal vaccine-induced disease from modified live virus vaccines and inadequate immune response to any vaccine in dogs receiving Zenrelia. It also has adverse event, warning, precaution, and contraindication information.

The letter details information omitted from the promotional materials and misrepresented study results. Elanco was told to respond with a list of all promotional materials that contain representations like those described in the letter and a plan to discontinue such communications or cease distribution of Zenrelia.