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Animal Drug Safety-Related Labeling Changes


This online resource provides information on recently approved safety-related labeling changes for animal drugs from January 2021 forward in an effort to improve transparency and communication with veterinarians and the public.

When adverse events are reported or safety concerns are identified for an animal drug, the FDA may work with the sponsor to revise the labeling to reflect this information. This webpage includes safety-related labeling changes initiated by the company or the FDA. Safety-related labeling changes include updates or revisions to any section of the label containing safety information. Awareness of these safety-related labeling changes is essential for the safe use and administration of FDA-approved animal products. 

There is often a lag between the approval of labeling changes and the new labeling becoming available in the marketplace. You can check this webpage for recent safety-related labeling changes as it will be updated on a regular basis when changes to the drug labeling are approved by the FDA. 

For more information about the most current labeling for a particular animal drug, veterinarians should reach out to the drug’s sponsor.


This webpage reflects recently approved safety-related labeling changes for FDA approved brand name new animal drugs and is also applicable to any generics of those products. Generic new animal drugs are copies of brand name new animal drugs approved by the FDA and must provide the same labeling information  (e.g., Indications, Warnings, Cautions, etc.). Therefore, the safety-related labeling changes reflected on this webpage also apply to generic new animal drugs.

The labeling for an approved animal drug, such as its carton or package insert, might not reflect the changes for a year or more in the marketplace as the drug company distributes its inventory of the drug with labeling printed prior to the approval of the labeling changes. 

Any reference to a commercial product, process, service, or company is not an endorsement or recommendation by the U.S. government, the Department of Health and Human Services, the FDA or any of its components. The FDA is not responsible for the contents of any non-FDA website referenced by or linked to the agency's website. 

Animal Drug Safety-Related Labeling Changes 2022-present:

Animal Drug Safety-Related Labeling Changes for previous years:


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