New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications

Resumen

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketing status from over-the- counter (OTC) use to use by veterinary feed directive (VFD) for these antimicrobial drugs of importance to human medicine, administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and abbreviated new animal drug applications (ANADAs) that were affected by this initiative.