FOOD AND DRUG ADMINISTRATION ISSUES RULE: NEW ANIMAL DRUGS; APPROVAL OF NEW ANIMAL DRUG APPLICATIONS; WITHDRAWAL OF APPROVAL OF NEW ANIMAL DRUG APPLICATIONS; CHANGE OF SPONSOR; CHANGE OF SPONSOR ADDRESS

WASHINGTON, Aug. 22 -- Food and Drug Administration has issued a rule called: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address.

The rule was published in the Federal Register on Aug. 22 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

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.

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