Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin

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The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of tulathromycin solution in cattle and in swine, by injection, for the management of respiratory disease. FDA is also amending the regulations to add the acceptable daily intake for total residues of tulathromycin and tolerances for residues of tulathromycin in edible tissues of cattle and swine.