2025-23914: Authorization of Emergency Use for Two Animal Drugs for the Treatment of New World Screwworm; Availability

Summary

The Food and Drug Administration (FDA or the Agency) is announcing the issuance of two Emergency Use Authorizations (EUA) (Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal drug products. FDA has issued one EUA for a new animal drug product as requested by Elanco US Inc. for the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) (NWS) larvae (myiasis) in dogs and puppies and one EUA for a new animal drug product as requested by Elanco US Inc. for the treatment of infestations caused by NWS larvae (myiasis) in cats and kittens. The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the August 18, 2025, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency, or a significant potential for a public health emergency, that affects or has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves NWS. On the basis of such determination, the Secretary of HHS declared on August 18, 2025, that circumstances exist justifying the authorization of emergency use of animal drugs to treat or prevent NWS myiasis in animals. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

The agency’s own summary, as published.