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  1. CVM Updates

“Approved by FDA” Labeling Statement Provides Assurance of Safety, Effectiveness of Animal Drugs

April 1, 2024

Veterinarians, pet owners, and animal producers can now easily determine if an animal drug is FDA-approved.

As required by amendments in the Animal Drug User Fee Act and Animal Generic Drug User Fee Act of 2018, the statement “Approved by FDA” must appear on the labeling of approved animal drugs in the marketplace. This statement is intended to help veterinarians, food animal producers, pet owners, and others clearly identify approved animal drugs and distinguish them from drugs that do not have the benefit of FDA approval. The FDA’s approval ensures that the drug is safe and effective for its intended use, properly manufactured, and adequately labeled and packaged. 

All FDA-approved animal drugs have a New Animal Drug Application (NADA) number or an Abbreviated New Animal Drug Application (ANADA) number. The Food, Drug, and Cosmetic Act (FD&C Act) requires that labeling for approved animal drugs include the six-digit application number as part of the following statement: 

“Approved by FDA under NADA # XXX-XXX” (for brand name animal drugs), or 
“Approved by FDA under ANADA # XXX-XXX” (for generic animal drugs).

The FDA considers approved animal drugs that don’t carry the statement on the labeling to be misbranded, and distributing such drugs violates the law. The FDA may take action, as appropriate, on drug labeling that does not follow the law.

You may not see the “Approved by FDA” statement on very small labeling components due to space restrictions. This statement is not allowed on the labeling for individual ingredients used to manufacture approved animal drugs, conditionally approved animal drugs, and indexed animal drugs for minor species. These animal drugs have different mandatory statements on their labeling. 

Since the requirement was implemented in the 2018 legislation, the FDA has been working with drug sponsors to update the labeling of all approved brand name and generic animal drugs to include the “Approved by FDA” statement. (A sponsor is the company that owns the right to market the drug.) If sponsors have an animal drug that is approved but not currently marketed, they will need to update the labeling with the required statement and submit the updated labeling to the FDA for approval before returning the drug to the market.

The “Approved by FDA” Statement on Medicated Feeds

The labeling for Type A medicated articles (animal drugs that are used to manufacture medicated feeds) is required to have the “Approved by FDA” statement. While the statement is not required on representative labeling (also known as “Blue Bird” labeling) for medicated feeds manufactured from Type A medicated articles, the FDA recommends that drug sponsors include it. If the statement is included on the Blue Bird labeling, then the final printed label for the medicated feed must also include the statement and this will reassure end users (for example, veterinarians and food animal producers) that the medicated feed was manufactured according to FDA-approved Blue Bird labeling.

The labeling of proprietary medicated feeds must also include the “Approved by FDA” statement. Proprietary feeds have formulas that are not publicly available and can only be manufactured by the licensed feed mills that are referenced in the NADA of the Type A medicated article. In some cases, the formulas are maintained under a Veterinary Master File (VMF), and the statement on the labeling for these proprietary medicated feeds may also include the VMF number:

“Approved by FDA under NADA # XXX-XXX
(maintained under VMF # XXX-XXX)”

For more information

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

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