# 2026-02331: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address

2026-02331, New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-02-06, effective 2026-02-06 (as of 2026-06-11).

- Canonical: https://policyrisk.com/federal-register/2026-02331
- As of: 2026-06-11
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-02331
- Title: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 5299
- Published: 2026-02-06
- Effective: 2026-02-06
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-11

## Summary

The FDA updated rules for new animal drugs approved between July and September 2025, including approvals, withdrawals, and sponsor changes. These updates affect drug makers, vets, and farmers by keeping drug info accurate and easy to find. The changes take effect February 6, 2026, helping everyone stay on the same page without extra costs.

## Abstract

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during July, August, and September 2025. The animal drug regulations are also being amended to improve their accuracy and readability.

## Effects PRIA read

- Animal drug rules updated (July–Sept 2025): benefit, low. The FDA amended animal drug regulations to reflect approvals, withdrawals, and sponsor changes for new animal drug applications during July, August, and September 2025. The rule is effective February 6, 2026. FDA says these updates affect drug makers, veterinarians, and farmers by keeping drug info…
- New drug use and withdrawal limits: cost, medium. The rule adds specific conditions of use for certain drugs. For doramectin in cattle, you may not slaughter treated cattle for human consumption within 35 days of treatment, it is not for use in female dairy cattle 20 months of age or older, no withdrawal period is established for preruminating cal…
- Fluralaner food-residue limits set: benefit, low. FDA established an acceptable daily intake (ADI) for total fluralaner residue of 10 micrograms per kilogram of body weight per day and tolerances for parent fluralaner in chickens: liver 320 ppb, muscle 110 ppb, and eggs 2500 ppb. These tolerances are tied to the fluralaner chicken use described in…

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## Sources
- [2026-02331 on federalregister.gov](https://www.federalregister.gov/documents/2026/02/06/2026-02331/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug)
- [2026-02331 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-02-06/pdf/2026-02331.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2026-02331 (as of 2026-06-11).