Authorization of Emergency Use for Four Animal Drugs for the Treatment of New World Screwworm; Availability

The Food and Drug Administration (FDA or the Agency) is announcing the issuance of four Emergency Use Authorizations (EUA) (Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal products. FDA has issued three EUAs for animal products as requested by Boehringer Ingelheim Animal Health USA, Inc. (Boehringer) for the prevention of infestations caused by New World screwworm (Cochliomyia hominivorax) (NWS) larvae (myiasis) in certain cattle, and for the treatment of such infestations in dogs, and cats. 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 NWS larvae (myiasis) in cattle, horses, minor species of hoof stock (e.g., sheep, goats, deer), raptors and other wild birds, pet birds, 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 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.

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