Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 43 supplemental new animal drug applications (NADAs) and 52 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) to prescription (Rx) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated drinking water. These applications were submitted in voluntary compliance with the goals of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative.