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

[Updated 09/25/2023] Today, the U.S. Food and Drug Administration (FDA) is announcing that it intends to temporarily exercise enforcement discretion for implementation of the labeling requirement mandated by section 502(w)(3) of the Federal Food, Drug and Cosmetic Act. The section requires an “Approved by FDA under NADA # XXX-XXX” or “Approved by FDA under ANADA # XXX-XXX” statement on all marketed and approved new animal drug and generic new animal drug labeling by September 30, 2023. The FDA has received feedback and questions from stakeholders about the implementation timeline for this requirement, often citing supply chain issues. The FDA intends to exercise enforcement discretion until March 30, 2024, for animal drug sponsors to incorporate their approved labeling revisions into product packaging.

The following message was sent to the Animal Drug Industry on July 7, 2023.

Introduction

This is a message to remind you that one of the following “Approved by FDA” 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

After September 30, 2023, marketed and approved new animal drugs and generic new animal drugs with labeling that does not comply with this requirement will be considered misbranded.

Most new animal drug sponsors have already submitted labeling supplements to their applications to ensure that all marketed and approved new and generic new animal drugs will bear compliant and FDA-approved labeling by the deadline. We remind you that all approved products marketed after the September 30, 2023, deadline must carry the appropriate revised statement on FDA-approved labeling.

Sponsors not compliant with this requirement by September 30, 2023, may face regulatory actions, including Warning letters. 

Any sponsors who have questions regarding implementation of this requirement for one or more of their approved and marketed new animal drug products should notify the Center for Veterinary Medicine immediately by sending an email to AskOSC@fda.hhs.gov. The email should include:

  1. The application number for the product in question,
  2. The date of approval (or anticipated date of submission) of the "Approved by FDA" labeling supplement,
  3. The expected date for distributing product bearing revised and approved labeling, and
  4. Your specific questions.

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, requires the labeling statement for all approved new animal drugs and abbreviated or generic new animal drugs. The intent of the labeling statement is to clearly identify approved animal drugs and differentiate those from animal drugs that are not approved. Approved new animal drugs that do not comply with this labeling requirement and that are marketed after the deadline will be considered misbranded.

Message

This labeling requirement applies to all approved animal drugs currently on the market, and this communication is a follow- up to our second Electronic Submissions System Broadcast Message on this topic sent on September 2, 2021.

The labeling for all approved animal drugs currently on the market will need to be revised by September 30, 2023, to either update or add the statement that matches exactly the applicable version in the new law.

Please 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.

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 an older 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 are 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 approved labeling for proprietary medicated feeds maintained under a Veterinary Master File (VMF), please present the statement on the labeling as follows:
           Approved by FDA under NADA # XXX-XXX 
          (maintained under VMF # XXX-XXX)
  • 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 remind you that updated distributor labeling should only be submitted to your DER file.

Contacts

We encourage you to contact the appropriate ONADE Target Animal Division regarding specific questions on placement of the statement and special circumstances for small or unique labeling. For questions after approval of your supplement, contact the Division of Pharmacovigilance and Surveillance by emailing to AskOSC@fda.hhs.gov. Again, in your email, please include:

  1. The application number for the product in question,
  2. The date of approval (or anticipated date of submission) of the "Approved by FDA" labeling supplement,
  3. The expected date for distributing product bearing revised and approved labeling, and
  4. Your specific questions.
 
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