Animal Drugs, Feeds, and Related Products; Tripelennamine Hydrochloride Injection

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The Food and Drug Administration (FDA) is amending the animal drug regulations to more clearly reflect the currently approved conditions of use of a new animal drug application (NADA) held by Solvay Animal Health, Inc. The NADA provides for use of tripelennamine hydrochloride injection for antihistaminic therapy in horses and cattle. The amendment provides for tolerances for drug residues in edible cattle tissues and in milk and the corresponding drug withdrawal and milk discard periods. When the NADA was reviewed under the National Academy of Sciences/National Research Council Drug Study Implementation Program and the results of the review finalized in 1983, this information was inadvertently omitted from the regulations.