Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry (GFI) #299 entitled "Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs With a New World Screwworm-Related Indication." This guidance is intended to inform new animal drug sponsors that dual labeling of a new animal drug product may include an intended use that is fully approved under section 512(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and an intended use that is conditionally approved under section 571 of the FD&C Act where the claim to be added to the existing product labeling is intended to treat or prevent New World screwworm myiasis.