GREENFIELD, Ind. (February 13, 2025) – Elanco Animal Health Incorporated issued the following statement regarding its commitment to clear veterinary and pet owner education following a promotional practices warning letter from U.S. Food and Drug Administration (FDA).
At Elanco, we are dedicated to helping veterinarians and pet owners help pets live longer, healthier, more active lives. Delivering new innovation to the marketplace and ensuring we clearly communicate with veterinarians and pet owners about how to safely and effectively use these products is a key part of that goal.
The U.S. FDA recently issued a Warning Letter to Elanco related to statements in Zenrelia™ (ilunocitinib tablets) promotional materials. The FDA uses these letters to notify companies of their positions and provide an opportunity to respond and make voluntary changes. We appreciate the FDA’s perspective and are working quickly to review and update Zenrelia promotional materials as appropriate.
Importantly, this letter is not related to the in-market product use experience; we are very pleased with Zenrelia's real-world performance. We appreciate the opportunity to work closely with the FDA to resolve the issues as we continue to help veterinarians and pet owners understand how their patients and pets can benefit from this exciting new product.
Elanco does not expect the adjustments to the promotional materials to have a material impact on Zenrelia revenue. The company continues to expect accelerating organic constant currency revenue growth to mid-single digits in 2025.
The entire FDA letter follows. For full prescribing information for Zenrelia, including the boxed warning, speak with your veterinarian, call 1 888 545 5973 or visit www.elancolabels.com/us/zenrelia.
INDICATIONS
Zenrelia is a prescription medication used to control itching and inflammation associated with skin allergies for dogs over 12 months of age.
IMPORTANT SAFETY INFORMATION
See package insert including the Boxed Warning. For full prescribing information speak with your veterinarian, call 1 888 545 5973 or visit www.elancolabels.com/us/zenrelia.
WARNING: VACCINE-INDUCED DISEASE AND INADEQUATE IMMUNE RESPONSE TO VACCINES. Based on results of the vaccine response study, dogs receiving Zenrelia are at risk of fatal vaccine-induced disease from modified live virus vaccines and inadequate immune response to any vaccine. Discontinue Zenrelia for at least 28 days to 3 months prior to vaccination and withhold Zenrelia for at least 28 days after vaccination. Dogs should be up to date on vaccinations prior to starting Zenrelia. Do not use in dogs less than 12 months old or dogs with a serious infection. Dogs should be monitored for the development of infections because Zenrelia may increase the chances of developing an infection. Neoplastic conditions (benign and malignant) were observed during clinical studies. The most common side effects were vomiting, diarrhea and tiredness. Zenrelia has not been tested in dogs used for breeding, pregnant, or lactating dogs and has not been evaluated in combination with glucocorticoids, cyclosporine, or other immune suppressive drugs.
ABOUT ELANCO
Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ sustainability pillars – all to advance the health of animals, people, the planet and our enterprise. Learn more at www.elanco.com.
