“Approved by FDA” is Mandatory on Labeling for Approved Animal Drugs – A Helpful Way for Veterinarians to Know if an Animal Drug is FDA-Approved

April 1, 2024

Dear Veterinarian,

You can now easily determine if an animal drug is FDA-approved. The statement “Approved by FDA” is mandatory on most labeling components for approved animal drugs. As required by amendments in the Animal Drug User Fee Act and Animal Generic Drug User Fee Act of 2018, the labeling statement is intended to help you clearly identify approved animal drugs and distinguish them from unapproved ones. The FDA’s approval ensures that the drug is safe and effective for its intended use, properly labeled, and manufactured according to current good manufacturing practices for animal drugs.

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 currently 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.

Since the requirement was implemented in the 2018 legislation, the FDA has been working with drug companies to update the labeling of all approved brand name and generic animal drugs to include the “Approved by FDA” statement. 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.

You may not see the statement on very small labeling components due to space restrictions. Also, the statement is not allowed on labeling for conditionally approved animal drugs and indexed animal drugs for minor species. These animal drugs have different mandatory statements on their labeling.

The “Approved by FDA” Statement on Medicated Feeds

If you’re a food animal veterinarian, please be aware that the labeling for Type A medicated articles (animal drugs that are used to manufacture medicated feed) 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 companies 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 means that the medicated feed was manufactured according to FDA-approved Blue Bird labeling.

The labeling of proprietary medicated feeds (often free-choice 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 FDA recommends the statement on the labeling for these proprietary medicated feeds should also include the VMF number:

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

The FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring safe, effective, and properly labeled drugs are available for animals. For more information, please contact CVM at 240-402-7002 or AskCVM@fda.hhs.gov.

Sincerely,

FDA’s Center for Veterinary Medicine