CVM GFI #299 -Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication: Guidance for Industry

Issue Date: October 14, 2025
Issued by: Center for Veterinary Medicine
Topic(s):
Status: Final

CVM GFI #299 -Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication: Guidance for Industry

This guidance is intended for sponsors seeking to combine fully approved and conditionally approved indications on a single new animal drug product label and labeling (dual labeling). The term “full approval” or “fully approved” is used herein when referring to an approval of a New Animal Drug Application (NADA) submitted under section 512(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The term “conditional approval” or “conditionally approved” is used when referring to approval of a Conditional NADA (CNADA) under section 571 of the FD&C Act.

Download the Guidance Document