Ophthalmic and Topical Dosage Form New Animal Drugs; Moxidectin

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 Fort Dodge Animal Health, Division of American Home Products Corp. The supplemental NADA provides for topical use of a 0.5 percent moxidectin solution on dairy cattle of breeding age for treatment and control of infections and infestations of certain internal and external parasites. FDA is also amending the regulations to establish a tolerance for moxidectin residues in milk.