FDA Issues Emergency Use Authorization for Over-the-Counter Injectable Drug to Prevent New World Screwworm in Cattle

U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for Ivomec (ivermectin) injectable solution against New World screwworm (NWS). The agency has concluded that based on the scientific evidence available, it is reasonable to believe that Ivomec may be effective for the prevention of infestations caused by NWS larvae (myiasis) in cattle when administered within 24 hours of birth, at the time of castration, or when a wound appears, and the known and potential benefits of the product outweigh its known and potential risks. 

Ivomec is not for use in female dairy cattle producing milk for human consumption and calves that will be processed for veal. The slaughter withdrawal period for cattle is 35 days.

This EUA will be effective until it is revoked or the HHS Secretary terminates the declaration that the potential public health emergency presented by NWS justifies the emergency use authorization of animal drugs for NWS.

Ivomec is available over the counter without a prescription. Producers are responsible for using Ivomec in accordance with the product labeling and fact sheet. To reduce the risk of antiparasitic resistance and preserve drug effectiveness against both NWS and other parasites, producers are encouraged to use antiparasitic drugs like Ivomec only when medically necessary and as part of a comprehensive parasite management strategy.  

The FDA has previously approved Ivomec to treat and control other parasites in cattle, swine, reindeer and American bison. 

Ivomec is sponsored by Boehringer Ingelheim Animal Health USA, Inc. based in Duluth, Georgia.