Key Takeaways
- Boehringer Ingelheim received an FDA Emergency Use Authorization (EUA) for IVOMEC® (ivermectin) 1% Injection.
- The authorization covers prevention of New World screwworm infestations in cattle at critical intervention points.
- This is the first EUA issued for an over-the-counter drug for NWS prevention in cattle.
- The authorization applies only during the declared emergency period and excludes certain cattle categories.
- The decision follows confirmed NWS cases in northern Mexico near the U.S. border.
Boehringer Ingelheim Granted FDA Emergency Use Authorization
Boehringer Ingelheim, a global animal health company, announced that the U.S. Food and Drug Administration has issued an Emergency Use Authorization for IVOMEC® (ivermectin) 1% Injection for the prevention of infestations caused by New World screwworm (Cochliomyia hominivorax) in cattle.
Under the EUA, IVOMEC® (ivermectin) 1% Injection is authorized for use when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound. The authorization excludes female dairy cattle producing milk for human consumption and calves intended for veal production. According to the FDA, there is no adequate, approved, and available alternative for preventing NWS infestations at these critical intervention points.
This marks the first Emergency Use Authorization for any over-the-counter drug aimed at preventing NWS infestations in cattle, providing access to a preventive option should an incursion occur in the United States.
Boehringer Ingelheim Highlights Role in Livestock Protection
“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.”
Boren added that the company appreciates the coordinated efforts of the FDA and U.S. Department of Agriculture in responding to emerging animal health risks and reaffirmed its commitment to supporting veterinarians, producers, and government agencies.
New World Screwworm Risk and Preparedness
New World screwworm is a parasitic fly whose larvae feed on living tissue, potentially causing severe injury or death in affected animals. While the parasite is not currently present in the United States, recent cases have been confirmed in livestock in northern Mexico, including Tamaulipas, which borders Texas.
“Having worked in regions where New World screwworm is endemic, I’ve seen firsthand that effective readiness depends on access to preventive tools,” said Dr. Gustavo Sabatini, Global Technical Manager for Ruminant Parasiticides at Boehringer Ingelheim. He noted that cattle are particularly vulnerable at birth and when wounds occur, making prevention a key component of preparedness.
Authorization Scope and Duration
The EUA for IVOMEC® (ivermectin) 1% Injection remains valid only for the duration of the emergency declaration under Section 564 of the Federal Food, Drug, and Cosmetic Act, unless revoked or terminated earlier by the FDA.
