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“Approved by FDA” Labeling Statement for Approved New Animal Drugs

The following message was sent to the Animal Drug Industry on May 16, 2019.

Introduction

This is a message to inform/remind all animal drug manufactures/sponsors that one of the following statements (as applicable) must be included on your approved (A)NADA labeling (except representative [Blue Bird] labeling) by September 30, 2023:

Approved by FDA under NADA # XXX-XXX, or
Approved by FDA under ANADA # XXX-XXX

Background

Section 502(w)(3) to the Federal Food, Drug, and Cosmetic Act, which was added by Section 303 of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, includes this labeling requirement for approved new animal drugs and abbreviated or generic new animal drugs. The intent of the labeling statements is to clearly identify approved animal drugs and differentiate those from animal drugs that are not approved.

Message

This labeling requirement applies to all approved animal drugs currently on the market. Many approved animal drugs already have a similar statement on at least some of their labeling. However, the labeling for all approved animal drugs currently on the market will need to be revised by September 30, 2023, with the statement that matches exactly the applicable version in the new law and to add the statement to labeling that does not currently have a statement.

If you have any (A)NADAs with labeling components for animal drug products that are approved but not currently marketed, you will need to update the labeling prior to returning the product to market. You may also request a voluntary withdrawal of approval for products that you are not planning to return to market.

Although the statement is not required on Blue Bird labeling, we recommend that you include it to clearly identify that the medicated feed was manufactured in accordance with FDA-approved Blue Bird labeling.

Please add the statement to your labeling and/or replace the current version of the statement with the new version. Use the exact format, upper/lower case letters, and spacing as presented above. Present the statement on a single straight line using the exact format and spacing as presented above. If there is insufficient space to present the statement on a single line, two straight lines is acceptable.

Regarding placement of the statement on labeling:

  • If a labeling component (other than Blue Bird labeling) currently has an older version of the statement, the revised version may be placed in the same location.
  • If a labeling component (other than Blue Bird labeling) does not currently have the statement:
    • For single-panel labeling components, including a single-sided package insert, place the statement near the end of the labeling component.
    • For a package insert that is multi-page, place the statement near the end of the last page.
    • For a Type A medicated article label that is single-paneled, or a proprietary Type B or Type C medicated feed label that is single-paneled, place the statement near the end of that panel. If multi-paneled, place the statement near the end of the back panel.
    • For other labeling components with several panels (e.g., front, sides, and/or back), place the statement at the bottom of the front panel.
  • For Blue Bird labeling, if you voluntarily add the statement or replace the current version with the new statement:
    • Move/place the statement near the end of the labeling, left-justified, above the “Manufactured by, Blue Bird Feed Mill, etc.” section.
    • Note that the “Approved by FDA” statement on Blue Bird labeling should be independent of, and separate from, footnotes identifying the source of the active drug ingredient in the medicated feed. Such footnotes typically include the proprietary name, NADA number, and/or sponsor of the individually approved Type A medicated article(s) (e.g., “Sourced from PROPRIETARY NAME, NADA # XXX-XXX”).
    • Also note that, on Blue Bird labeling for combination medicated feeds, the “Approved by FDA” statement will use the A/NADA number of the approved combination, whereas the footnotes will use the A/NADA numbers of the individual Type A medicated articles approved for use in the combination.

We recommend that you do the following:

  • Comply early with this requirement.
  • Submit the updated labeling as an NL supplement to your (A)NADA, unless you are making other changes to the labeling, in which case the other changes will determine whether it is an NL, NF, or different type of supplement.
  • Be sure to indicate in the supplement (e.g., in eSubmitter/the cover letter, under purpose of submission) that you are adding or updating the statement on the labeling.

We remind you that updated distributor labeling should only be submitted to your DER file.

Contacts

We further encourage you to contact the appropriate Target Animal Division regarding specific questions on placement of the statement and special circumstances for small or unique labeling. You may also contact your ONADE Project Manager on general questions about this new labeling requirement.

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