On September 23, 2025, Elanco Animal Health announced that the U.S. Food and Drug Administration approved an improved label for its canine dermatology product Zenrelia. The FDA decision removed the risk language that previously warned of fatal vaccine‑induced disease, a change that brings the U.S. label into alignment with those in the European Union, Great Britain, Brazil, and Japan.
The updated label retains the boxed warning that advises veterinarians to discontinue Zenrelia for at least 28 days to three months before vaccination and to withhold the drug for at least 28 days after vaccination, citing the risk of an inadequate immune response to vaccines. The removal of the vaccine‑induced disease language was based on additional data submitted by Elanco, which the FDA concluded supported the change.
Zenrelia has already treated more than half a million dogs worldwide. In the United States, more than 90% of veterinarians are aware of the product and 80% of U.S. clinics have reordered Zenrelia after initial use, indicating strong market penetration. The label update is expected to further ease prescriber concerns and could accelerate adoption in new veterinary practices.
Elanco’s Executive Vice President of Research & Development, Dr. Ellen DeBrabander, said the FDA’s decision “brings the U.S. label a step closer to the approved Zenrelia label in other major markets.” Executive Vice President of U.S. Pet Health and Global Digital Transformation, Bobby Modi, added that the update “makes it easier for veterinarians to discuss Zenrelia with pet owners.”
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