Elanco Animal Health Incorporated issued a statement on February 13, 2025, confirming it received a Warning Letter from the U.S. Food and Drug Administration (FDA) related to statements in Zenrelia promotional materials. The FDA noted false or misleading claims and representations about the safety and effectiveness of Zenrelia.
The FDA's letter specifically cited omissions of critical safety information, such as the phrase 'from modified live virus vaccines' from the boxed warning and the specific time period to withhold Zenrelia before and after vaccination. It also highlighted misrepresented study results that contradicted the product's Prescribing Information.
Elanco stated that the letter is not related to the in-market product use experience and that it is working to review and update Zenrelia promotional materials. The company does not expect these adjustments to have a material impact on Zenrelia revenue and continues to anticipate accelerating organic constant currency revenue growth to mid-single digits in 2025.
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