Authorization of Emergency Use for Four Animal Drugs for the Treatment of New World Screwworm; Availability
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The FDA has authorized the emergency use of four animal drugs to prevent and treat infestations caused by the New World screwworm in animals. This affects cattle, horses, certain bird species, and various zoo mammals. The action ensures that these animals can be protected and treated effectively during potential public health emergencies.
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Key Changes
- FDA authorizes emergency use of four animal drugs.
- Drugs target prevention and treatment of New World screwworm infestations.
- Affects cattle, horses, some bird species, and zoo mammals.
Obligations
What this law requires
Boehringer Ingelheim Animal Health USA, Inc. must ensure the authorized use of Ivomec (ivermectin) in cattle for the prevention of New World screwworm infestations, subject to the terms of its Emergency Use Authorization.
Animal health companies must ensure the emergency use of the authorized animal drugs for the treatment of New World screwworm complies with all conditions outlined in the FDA's Authorizations.
Animal health companies must submit written requests for single copies of the Emergency Use Authorizations to the Policy and Regulations Staff at FDA.
Boehringer Ingelheim Animal Health USA, Inc. must ensure the authorized use of NexGard (afoxolaner) and NexGard COMBO (esafoxolaner, eprinomectin, and praziquantel topical solution) in dogs and cats for the treatment and prevention of New World screwworm infestations, subject to the terms of their Emergency Use Authorization.
The FDA must publish a notice of each authorization in the Federal Register, along with an explanation of reasons for the action.