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

WASHINGTON, May 9 -- 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.

The rule was published in the Federal Register on May 9 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 January, February, and March 2025. The animal drug regulations are also being amended to imp...