New Animal Drugs for Use in Animal Feeds; Oxytetracycline Type A Medicated Articles

摘要

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides revised labeling for Pfizer's pioneer, Type A, oxytetracycline- containing, medicated articles which brings the products into compliance with the findings of the National Academy of Sciences/ National Research Council (NAS/NRC), Drug Efficacy Study Group's (DESI) effectiveness evaluation and subsequent FDA conclusions. In addition, the regulations are further amended to reflect approval, based on FDA's DESI ``me-too'' policy, of one original NADA each filed by Pfizer and PennField Oil Co. for Type A medicated articles that are copies of the Pfizer pioneer products.