Oral Dosage Form New Animal Drugs; Piperazine

Resumo

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 Fleming Laboratories, Inc. The supplemental NADA provides for the safe and effective use of piperazine in chickens, turkeys, and swine for the treatment of certain parasitic infections. The approval reflects compliance with the results of the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Implementation (DESI) evaluation of the effectiveness of piperazine and FDA's conclusions concerning that evaluation. FDA also is amending the regulations to provide tolerances for piperazine residues.