Emergency use authorization secured for injection to help protect against New World screwworm
FDA grants first Emergency Use Authorization for an over-the-counter product for the prevention of New World screwworm infestations in cattle
Ongoing detections in Mexico heighten the importance of readiness and access to preventive tools for U.S. livestock
Boehringer Ingelheim Feb. 5 announced that the U.S. Food and Drug Administration has issued an Emergency Use Authorization for the use of IVOMEC (ivermectin) 1% Injection for the prevention of infestations caused by New World screwworm in cattle.
Under the EUA, IVOMEC (ivermectin) 1% Injection is authorized for the prevention of infestations caused by NWS (Cochliomyia hominivorax) larvae (myiasis) when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound in cattle, except for female dairy cattle producing milk for human consumption and calves that will be processed for veal. Based on available scientific evidence, FDA determined that there is no adequate, approved, and available alternative to the product for the prevention of NWS in certain cattle at these critical intervention points. This is the first EUA for any over-the-counter drug for the prevention of infestations caused by NWS in cattle, providing timely access to a preventive tool should an NWS incursion occur in the United States.
“Protecting the health and well‑being of livestock is at the core of our mission,” said Steve Boren, vice president, U.S. Livestock, Boehringer Ingelheim in a news release. “Emergency Use Authorization for IVOMEC (ivermectin) 1% Injection provides cattle producers and veterinarians with an important preventive tool against New World screwworm. We appreciate the proactive approach of the FDA and USDA in response to this emerging animal health threat and remain dedicated to supporting veterinarians, producers, and government as we work together to protect cattle herds.”
NWS is a parasitic fly whose larvae feed on the living tissue of warm‑blooded animals, causing serious tissue damage and potentially fatal infestations. Although NWS is not currently present in the United States, recent cases have been confirmed in livestock in northern Mexico, including in Tamaulipas, a border state adjacent to Texas. More information about NWS and the unified federal response is available at screwworm.gov.
“Having worked in regions where New World screwworm is endemic, I’ve seen firsthand that effective readiness depends on access to preventive tools and strong producer education,” said Dr. Gustavo Sabatini, global technical manager for ruminant parasiticides at Boehringer Ingelheim, who recently testified before the Texas House Agriculture and Livestock Committee on NWS preparedness alongside federal and state animal health officials and industry groups. “Screwworm strikes cattle when they are most vulnerable, including at birth, and demands more labor‑intensive management on the ground. That’s why prevention is essential – not only to protect animal health, but also to safeguard the food supply and the livelihoods of cattle producers.”
IVOMEC (ivermectin) 1% Injection is authorized for this use only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of IVOMEC (ivermectin) 1% Injection under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
For more information, please visit the IVOMEC (ivermectin) 1% Injection EUA Fact Sheet at www.boehringer-ingelheim.com.
