Federal Register #FDA-2026-N-0004

FDA Emergency Use Authorization for Animal Drugs to Combat New World Screwworm

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued Emergency Use Authorizations (EUAs) for three animal drugs to address New World screwworm (NWS) infestations in animals. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Center for Veterinary Medicine - OEMs and Vendors: - Zoetis Inc. - Felix Pharmaceuticals Pvt. Ltd. - Alberta Vet Labs Ltd. - Products/Services Requested: - Dectomax/Dectomax-CA1 (doramectin injection) by Zoetis Inc. - For prevention and treatment of NWS in dairy cattle, horses, swine, sheep, and deer - Nitenpyram Tablets (nitenpyram) by Felix Pharmaceuticals Pvt. Ltd. - For treatment of NWS in dogs, puppies, cats, and kittens - Ivermectin Liquid for Horses (ivermectin oral solution) by Alberta Vet Labs Ltd. - For short-term prevention of NWS in horses - Unique or Notable Requirements: - These EUAs are issued in response to a public health emergency declaration regarding New World screwworm - Each drug is authorized for specific animal species and use cases - No specific purchase quantities or part numbers are provided - The authorizations include conditions for emergency use and are effective from their respective issuance dates

Description

The Food and Drug Administration (FDA) has issued three Emergency Use Authorizations (EUAs) for new animal drugs to prevent and treat infestations caused by New World screwworm (NWS) larvae. These authorizations cover products for dairy cattle, horses, swine, sheep, deer, dogs, puppies, cats, and kittens. The EUAs follow a determination by the Secretary of Health and Human Services that there is a significant potential for a public health emergency involving NWS. The authorizations include conditions on the emergency use of the products and are effective on their respective issuance dates in 2026.

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