The labeling of approved animal drugs must now include the statement “Approved by FDA” so that veterinarians, food animal producers and pet owners can clearly identify medications permitted by the U.S. Food and Drug Administration.
Under the requirement, FDA-approved animal drugs must have a New Animal Drug Application (NADA) number or an Abbreviated New Animal Drug Application (ANADA) number. As described in the Federal Food, Drug and Cosmetic Act, the labeling of approved animal drugs must include the six-digit application number in one of the following statements:
- “Approved by FDA under NADA # XXX-XXX” for brand name animal drugs.
- “Approved by FDA under ANADA # XXX-XXX” for generic animal drugs.
If an approved animal drug is not labeled correctly, the agency will consider the medication misbranded, and any distribution will violate the law.
“Approved by FDA” labeling is not allowed for individual ingredients used to manufacture approved animal drugs or conditionally approved or indexed animal drugs for minor species, according to the agency.
Following amendments to the 2018 Animal Drug User Fee Act and the Animal Generic Drug User Fee Act, the FDA has worked with drug sponsors to include “Approved by FDA” on all approved brand-name and generic animal medications and medicated feeds. If sponsors have an approved product not currently sold, they must update the label with the required statement and submit it to the federal agency for approval before marketing the drug.