Notice of Approval of Supplemental New Animal Drug Application; Moxidectin

Streszczenie

The Food and Drug Administration (FDA) is providing notice that it has approved a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The approved NADA provides for the veterinary prescription use of a sustained-release injectable moxidectin formulation for prevention of heartworm disease and treatment of existing hookworm infections in dogs. The supplemental NADA adds animal safety information to product labeling.