Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone Acetate and Estradiol

Riepilogo

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Intervet Inc.; three supplemental abbreviated new animal drug applications (ANADAs) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc.; and a supplemental ANADA filed by Fort Dodge Animal Health, Division of Wyeth. The supplemental NADAs and ANADAs provide for the addition of statements to labeling of subcutaneous implants containing trenbolone acetate and estradiol warning against the use of these products in calves to be processed for veal.