Oral Dosage Form New Animal Drugs; Ivermectin with Pyrantel Pamoate

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 Merck Research Laboratories, Division of Merck & Co., Inc., for a chewable tablet containing ivermectin in combination with pyrantel pamoate. The product is used to prevent canine heartworm disease and to treat and control ascarid and hookworm infections in dogs. The supplemental NADA provides for extending the use in dogs to those weighing less than 5 pounds and for revising the limitation in the regulation concerning use in dogs under 6 weeks of age.