CVM GFI #299 -Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication Guidance for Industry October 2025

GUIDANCE DOCUMENT

• Docket Number: FDA-2025-D-4500
• Issued by: Center for Veterinary Medicine

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.

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All written comments should be identified with this document's docket number: FDA-2025-D-4500.

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