FDA Issues Emergency Use Authorization for Credelio CAT to Treat New World Screwworm in Cats

Today the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for Credelio CAT (lotilaner chewable tablets). The agency has concluded that based on the scientific evidence available, it is reasonable to believe that Credelio CAT may be effective in treating New World screwworm (NWS) infestations in cats and kittens, and the known and potential benefits of the product outweigh its known and potential risks. This is the first drug authorized by the FDA for the treatment of NWS in cats.

This EUA will be effective until it is revoked or the HHS Secretary terminates the declaration that NWS presents a significant potential for a public health emergency.

Most cats in America are at low risk of NWS due to their geographic location; however, outdoor cats near the U.S.-Mexico border and cats that have traveled to countries with active NWS cases are more likely to be exposed to NWS.

Credelio CAT is available only by prescription from a licensed veterinarian because professional expertise is required to monitor for and respond to potential adverse reactions. Detailed product information for veterinary practitioners can be found in the Fact Sheet for Veterinarians: Emergency Use Authorization of Credelio CAT (lotilaner).

Lotilaner, the active ingredient in Credelio CAT, belongs to a class of antiparasitic drugs called isoxazolines. Although isoxazoline products are commonly used and safe for most cats, the products have been associated with neurologic adverse reactions, including muscle tremors, ataxia, and seizures. Cat owners should consult with a veterinarian to determine whether Credelio CAT is appropriate for their cat.

The FDA originally approved Credelio CAT in 2019 for flea and tick-related indications in cats and kittens.  

Credelio CAT is sponsored by Elanco US Inc. based in Indianapolis, Indiana.