Elanco Reinforces Commitment to Veterinary and Pet Owner Education

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 click here.