Zoetis has submitted a supplement to the U.S. Food and Drug Administration to update the Librela label, incorporating post-approval experience since its launch in the U.S. in October 2023. The label has been updated to provide current information on real-world drug experience reporting.
Source: Zoetis, February 4, 2025. Link. The updates to the label include:
- A statement was added to the beginning of the Dosage and Administration section regarding the Client Information Sheet and potential adverse events
- Addition of a post approval experience section
- Addition of an Information for Dog Owners section
- Addition of a Client Information Sheet
There is no change to the contraindications, warnings or precautions on the Librela label. The revised label, www.LibrelaPI.com, reflects reported adverse events from dogs treated with Librela in the U.S.
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