- FDA grants Emergency Use Authorization for IVOMEC® (ivermectin) 1% Injection
- First EUA issued for an over-the-counter product to prevent New World screwworm in cattle
- Authorized for use at birth, castration, or when wounds appear
- Excludes dairy cattle producing milk for human consumption and veal calves
- Authorization responds to ongoing New World screwworm detections in northern Mexico
- Provides cattle producers and veterinarians with a preventive tool to support U.S. livestock readiness
The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for IVOMEC® (ivermectin) 1% Injection, allowing its use to help prevent infestations caused by New World screwworm (Cochliomyia hominivorax) in cattle, according to an announcement from Boehringer Ingelheim.
The authorization represents a significant milestone in U.S. livestock preparedness, as it is the first EUA granted for an over-the-counter product aimed at preventing New World screwworm infestations in cattle. The FDA determined that no adequate, approved, and available alternatives currently exist for preventing infestations at critical points when cattle are most vulnerable.
Use Authorized at High-Risk Intervention Points
Under the EUA, IVOMEC® (ivermectin) 1% Injection may be administered for prevention of screwworm infestation when cattle are at highest risk, including within 24 hours of birth, at the time of castration, or upon the appearance of a wound. The authorization does not apply to female dairy cattle producing milk for human consumption or to calves intended for veal production.
By enabling use at these intervention points, the EUA provides cattle producers and veterinarians with timely access to a preventive option should New World screwworm be detected in the United States.
Regional Detections Heighten Preparedness Efforts
While New World screwworm has been eradicated from the U.S. for decades, recent detections in northern Mexico, including in the border state of Tamaulipas, have raised concern among federal and state animal health authorities. The parasitic fly’s larvae feed on the living tissue of warm-blooded animals, causing severe tissue damage that can be fatal if left untreated.
Federal agencies, industry partners, and livestock organizations have emphasized the importance of readiness, surveillance, and access to preventive tools as part of a unified response.
Authorization Duration and Safety Considerations
The EUA remains in effect only for the duration of the federal declaration under Section 564 of the Federal Food, Drug, and Cosmetic Act, unless revoked earlier.
IVOMEC® (ivermectin) 1% Injection carries important safety restrictions, including slaughter withdrawal periods, and should not be used in dairy cattle of breeding age, veal calves, or species not listed on the label.
Information sourced from the company’s press release.
