Implantation or Injectable Dosage Form New Animal Drugs; Doramectin

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 Pfizer, Inc. The supplemental NADA provides for use of doramectin in cattle to control infections and to protect from reinfection with Cooperia punctata and Dictyocaulus viviparus for 28 days after treatment. This supplemental NADA also amends the wording of the claim for protection against infection or reinfection with Ostertagia ostertagi for 21 days and incorporates the claim into the new indication statement.