New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
Published Date: 2/6/2026
Rule
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.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
New drug use and withdrawal limits
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 calves, and do not use in calves to be processed for veal. For fluralaner oral solution in chickens, treated chickens must not be slaughtered for human consumption for 11 days after the last treatment, and no egg discard is required when used according to labeling.
Animal drug rules updated (July–Sept 2025)
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 information accurate and easy to find and that the changes take effect without extra costs.
Fluralaner food-residue limits set
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 Sec. 520.999.
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Key Dates
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