Elanco Animal Health Inc. Announces FDA Approves Updated Zenrelia™ Label, Removing Vaccine-Induced Disease Warning
Reuters
Sep 23
Elanco Animal Health Inc. Announces FDA Approves Updated Zenrelia™ Label, Removing Vaccine-Induced Disease Warning
Elanco Animal Health Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for Zenrelia™ (ilunocitinib tablets), removing language related to the risk of fatal vaccine-induced disease from modified live virus vaccines. This decision follows a thorough review of supplemental scientific data, which has since been peer-reviewed and published, supporting the safety and efficacy of Zenrelia. The updated label aligns more closely with those in other markets such as the European Union, Great Britain, Brazil, and Japan. Elanco continues to commit to generating additional data to further strengthen the U.S. label. Zenrelia is a once-daily oral JAK inhibitor used for controlling itching and inflammation in dogs with skin allergies and has been used to treat over half a million dogs worldwide.
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