Federal Register · Regulatory notice

Authorization of Emergency Use for Three Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability

The Food and Drug Administration (FDA or the Agency) is announcing the issuance of three Emergency Use Authorizations (EUA or Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal products. FDA has issued one EUA for an animal product as requested by Zoetis Inc. for the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax; NWS) larvae (myiasis) in dairy cattle, horses, swine, sheep, and deer. FDA has issued one EUA for an animal product as requested by Felix Pharmaceuticals Pvt. Ltd. for the treatment of infestations caused by NWS myiasis in dogs, puppies, cats, and kittens. FDA has issued one EUA for an animal product as requested by Alberta Vet Labs Ltd for the short-term prevention of infestations caused by NWS myiasis in horses. 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 significant potential for a public health emergency that 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.