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

摘要

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 products. FDA has issued one EUA for an animal product as requested by Health and Hygiene (Pty) Ltd. for the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) (NWS) larvae (myiasis) in cattle, horses, minor species of hoof stock, raptors and other wild birds, pet birds, and captive wild, exotic, and zoo mammals. FDA has issued one EUA for an animal product as requested by Elanco US Inc. for the prevention and treatment of infestations caused by NWS larvae (myiasis) in cattle, swine, goats, sheep, horses, donkeys, domestic hybrid equids, and captive wild, exotic, and zoo mammals. 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