Boehringer Ingelheim's New Tool for Cattle Protection
In a significant development for cattle producers, Boehringer Ingelheim has announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for IVOMEC® (ivermectin) 1% Injection. This product is designed to offer preventive measures against infestations caused by the New World screwworm (NWS) in cattle.
FDA's Landmark Decision
The issuance of the EUA represents a milestone as it is the first emergency authorization of an over-the-counter drug specifically for the purpose of preventing New World screwworm infestations in cattle. This preventive measure is critical, especially given the recent detections of NWS in livestock in Mexico, which underscore the need for readiness and access to effective solutions for livestock owners in the U.S.
Conditions for Use
The IVOMEC (ivermectin) 1% Injection is approved for use during crucial moments for cattle: within 24 hours of birth, at the time of castration, or when a wound is first noticed. However, it is important to note that the product is not authorized for use in female dairy cattle that produce milk for human consumption or in calves intended for veal production. The FDA has determined that there are no adequate, approved substitutes for this preventive treatment in these critical situations.
Protecting Livestock Health
Steve Boren, Vice President of U.S. Livestock at Boehringer Ingelheim, emphasized the company’s commitment to the health and welfare of livestock, stating, "Emergency Use Authorization for IVOMEC® provides cattle producers with a crucial preventive tool against New World screwworm. We appreciate the swift action of the FDA and USDA in combating this emerging threat to animal health, and we remain devoted to assisting veterinarians and producers during this critical time.”
The Impacts of New World Screwworm
The New World screwworm is a parasite that poses severe risks to the health of livestock, as its larvae can inflict catastrophic tissue damage and lead to fatal infestations. While NWS is not presently established in the United States, its recent appearance in northern Mexico serves as a dire warning. Awareness and proactive measures are essential to protecting herd health and safeguarding food supply chains.
Expert Insights on Prevention
Dr. Gustavo Sabatini, a Global Technical Manager at Boehringer Ingelheim, noted the critical importance of being prepared against NWS, having experience in regions where this threat is prevalent. He highlights the necessity for producers to have access to effective preventive measures. “Screwworm infestations typically occur at vulnerable stages in cattle's lives, and thus, prevention is crucial not only for animal health but for the livelihood of farmers and the safety of our food supply,” he stated.
Regulatory Framework for IVOMEC
The authorization of IVOMEC (ivermectin) 1% Injection remains valid as long as the FDA's declaration of emergency use continues. This means that the context surrounding its use must be continually monitored to ensure it aligns with prevailing regulations and safety standards.
Safety Information
It is important for users to be aware of essential safety guidelines associated with IVOMEC (ivermectin) 1% Injection. Treatment of cattle within 35 days of slaughter is prohibited. Additionally, the product should not be used on female dairy cattle of breeding age or veal calves due to safety concerns. The use in other animal species, which are not specified in the label, may also result in severe adverse reactions.
About Boehringer Ingelheim
Boehringer Ingelheim is a prominent force in animal health, dedicating extensive resources toward innovation in preventing and treating animal diseases. The company’s offerings include vaccines and treatment technologies aimed at promoting animal health across diverse species. As a leader in the field, Boehringer Ingelheim recognizes the strong interconnection between human and animal health, striving to contribute positively to the community and society at large.
Frequently Asked Questions
What is IVOMEC® (ivermectin) 1% Injection used for?
IVOMEC® is used to prevent infestations of New World screwworm in cattle during critical times such as shortly after birth or at the first sign of injury.
What authorization has the FDA granted for IVOMEC?
The FDA issued Emergency Use Authorization for IVOMEC® to provide a preventive measure against NWS infestations in cattle.
Why is the New World screwworm a concern?
The New World screwworm can severely damage livestock by feeding on living tissue, leading to painful conditions and potentially fatal outcomes.
Are there any restrictions on using IVOMEC?
Yes, IVOMEC should not be used on female dairy cattle producing milk for humans or on calves intended for veal.
How does Boehringer Ingelheim contribute to animal health?
Boehringer Ingelheim focuses on research and innovation to develop treatments and vaccines aimed at improving livestock health, thereby ensuring a safer food supply.
