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

WASHINGTON, April 16 -- 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 Application; Change of Sponsor; Change of Sponsor Address.

The rule was published in the Federal Register on April 16 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), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during October, November, and December 2025. The animal drug regul...