The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets to authorize both products for the prevention and treatment of New World Screwworm (NWS) infestations in dogs, puppies, cats, and kittens.
The authorization applies to pets that weigh at least two pounds and are at least four weeks old. Previously, the authorization for Nitenpyram Tablets was limited to treatment only. The FDA stated that this expansion addresses a previously unmet need by providing tools to protect pets from NWS infestations.
Currently, most dogs and cats in the U.S. are at low risk due to confirmed cases being limited to a specific geographic region. However, the FDA advises that pets living in, traveling to, or returning from areas where NWS infestations have been identified by state or federal officials, or certain countries south of the U.S. border, should be monitored for signs such as visible maggots or foul odors in wounds.
Capstar and Nitenpyram Tablets are available over the counter and come in two tablet sizes: 11.4 mg and 57 mg. Dosage is determined by the pet's weight. The products should not be administered to pets younger than four weeks or those weighing less than two pounds.
Based on the totality of scientific evidence, the FDA concluded that the known and potential benefits of the products outweigh their known and potential risks when used as authorized.
Capstar is sponsored by Sergeant’s Pet Care Products LLC of Omaha, Nebraska. Nitenpyram Tablets are sponsored by Felix Pharmaceuticals Pvt. Ltd., based in Ireland.
