Primary source: Letter of Authorization: Bimectin injection (EUA 006729)
Emergency Use Authorization for Bimectin (ivermectin) injection is now in effect, allowing its use in cattle to prevent New World screwworm infestations under specific conditions.
The EUA expands treatment options for preventing a significant agricultural challenge with New World screwworms, ensuring that cattle producers have access to effective interventions while emphasizing safety standards.
Cattle producers must administer Bimectin injection within specified timelines (24 hours post-birth, at castration, or on wound appearance) and observe a 35-day withdrawal period before slaughter to prevent drug residues in food.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Cattle producers must administer Bimectin injection within specified timelines (24 hours post-birth, at castration, or on wound appearance) and observe a 35-day withdrawal period before slaughter to prevent drug residues in food.
The FDA issued an Emergency Use Authorization (EUA) for Bimectin (ivermectin) injection for preventing New World screwworm infestations in cattle when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound. It is not authorized for use in lactating dairy cows or calves processed for veal, and must be used following strict guidelines to ensure safety and effectiveness.
What changed: Emergency Use Authorization for Bimectin (ivermectin) injection is now in effect, allowing its use in cattle to prevent New World screwworm infestations under specific conditions.
Why it matters: The EUA expands treatment options for preventing a significant agricultural challenge with New World screwworms, ensuring that cattle producers have access to effective interventions while emphasizing safety standards.
Practical implication: Cattle producers must administer Bimectin injection within specified timelines (24 hours post-birth, at castration, or on wound appearance) and observe a 35-day withdrawal period before slaughter to prevent drug residues in food.
Published from the regulator source ingestion pipeline after PV impact triage.
Implement enhanced surveillance and tracking of Salmonella cases linked to imported eggs, potentially increasing ICSR submissions related to these infections.
Compounding pharmacies must verify that all components used in injectable drugs are suitable for their intended use and discontinue the use of any glutathione labeled for dietary supplement purposes, particularly if sourced from Medisca.
Update product labeling to include Lisraya as the first oral treatment for dermatomyositis, ensuring that all marketing and educational materials reflect its approval and associated safety information.
Review and update internal compliance and reporting workflows to align with the FDA's reporting requirements for the latest oncology product approvals.
