Authorization of Emergency Use for Four Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability
What this record is not
Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or the Agency) is announcing the issuance of four 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 Elanco US Inc. for application on or around wounds for the prevention of infestations caused by New World screwworm (Cochliomyia hominivorax; NWS) larvae (myiasis) in sheep, cattle, goats, swine, camelids, and the following captive and captured wildlife species: cervids, American bison, bighorn sheep, and Sonoran pronghorn. FDA has issued one EUA for an animal product as requested by Zoetis Inc. for the treatment of infestations caused by NWS (myiasis) in dogs and puppies. FDA has issued one EUA for an animal product as requested by Bimeda Animal Health Ltd. for the prevention of infestations caused by NWS (myiasis) in cattle. FDA has issued one EUA for an animal product as requested by Sergeant's Pet Care Products LLC for the treatment and prevention of infestations caused by NWS (myiasis) in dogs, puppies, cats and kittens 2 pounds of body weight or greater and 4 weeks of age and older. 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.
Abstract as published in the Federal Register.
READ THE FULL DOCUMENT
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.
Create a free account