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BIVI SECURES EMERGENCY USE AUTHORIZATION FOR IVOMEC FOR NEW WORLD SCREWWORM
Source: Boehringer Ingelheim news release

DULUTH, Ga. - Boehringer Ingelheim, a global leader in animal health, today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the use of IVOMEC (ivermectin) 1% Injection for the prevention of infestations caused by New World screwworm (NWS) 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.1 This is the first EUA for any over-the-counter drug for the prevention of infestations caused by NWS in cattle,1 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. "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.2 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.3 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 here.BIVI

About Boehringer Ingelheim - Animal Health business

Boehringer Ingelheim provides innovation for preventing and treating diseases in animals. The company offers a wide range of vaccines, parasite-control products, and medicines for pets, horses, and livestock to veterinarians, animal owners, farmers, and governments. As a leader in animal health, Boehringer Ingelheim values that the health of humans and animals is deeply connected and strives to make a difference for people, animals, and society. Learn more at www.boehringer-ingelheim.com/us/animal-health.

About Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com. 


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