Zoetis Inc. announced on February 4, 2025, an update to the U.S. label for Librela® (bedinvetmab injection), its treatment for canine osteoarthritis (OA) pain. This update follows the submission of a supplement to the U.S. Food and Drug Administration (FDA) based on post-approval experience since the product's U.S. launch in October 2023.
The company stated its confidence in the safety and effectiveness of Librela, which has been used to treat over one million dogs in the U.S. The label updates are based on real-world drug experience data reported to the agency and collected through Zoetis’ pharmacovigilance monitoring.
Zoetis is immediately implementing the updated label and providing associated Client Information Sheets to veterinarians, along with ongoing resources and medical education. The company emphasized that label updates are not uncommon, particularly in the initial years post-launch, in response to real-world data.
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