New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 528, and 558 [Docket No. FDA-2025-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments. SUMMARY: 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) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2025. The animal drug regulations are also being amended to improve their accuracy and readability. DATES: This rule is effective August 22, 2025. FOR FURTHER INFORMATION CONTACT: Cathie Marshall, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5693, cathie.marshall@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Approval of Applications FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during April, May, and June 2025, as listed in table 1. Documentation of environmental review required under the National Environmental Policy Act, summaries of the basis of approval under the Freedom of Information Act (FOIA summaries), and marketing exclusivity and patent information are available at Animal Drugs @FDA: https://animaldrugsatfda.fda.gov/​adafda/​views/​#/​search . Table 1—Original And Supplemental Applications Approved During April, May, and June 2025 Date of approval Appl…