Implantation or Injectable Dosage Form New Animal Drugs; Zeranol

Resumen

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for use of a subcutaneous ear implant containing zeranol in pasture cattle for increased rate of weight gain. FDA is also amending the regulations to add the acceptable daily intake (ADI) for total residues of zeranol.