FDA Greenlights Double Labels to Fight Screwworm in Livestock
Published Date: 10/16/2025
Notice
Summary
The FDA just released new guidance letting animal drug makers put two labels on one product—one fully approved and one conditionally approved—to fight the pesky New World screwworm. This helps companies update their products faster without extra costs or delays. If you make or sell animal drugs, this change means smoother labeling and quicker protection for animals starting now.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA Allows Dual Drug Labeling
On October 16, 2025 the FDA issued final Guidance for Industry #299 that says a single new animal drug product label may include both an intended use fully approved under section 512(b) of the FD&C Act and an intended use conditionally approved under section 571 for treating or preventing New World screwworm (Cochliomyia hominivorax). This 'dual labeling' guidance applies specifically when the added claim is for New World screwworm myiasis.
Guidance Effective Immediately for NWS
The FDA issued this guidance immediately effective on October 16, 2025 so the Agency can act expeditiously to review and, where appropriate, approve or authorize animal drugs for New World screwworm (NWS) myiasis; FDA said it is issuing the guidance now because NWS has progressed north since 2022 and is approaching the U.S. border with Mexico and poses an emerging threat to livestock, pets, wildlife, and food security.
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