July 17, 2025

The U.S. Food and Drug Administration approved Exzolt (fluralaner oral solution) for the treatment and control of northern fowl mites (Ornithonyssus sylviarum) in laying hens and replacement chickens. This is the first FDA-approved product for this indication and the first oral product for the treatment and control of northern fowl mites in poultry. 

In addition to establishing that fluralaner is safe and effective in laying hens and replacement chickens, the FDA determined that residues in edible tissues or eggs from birds treated with Exzolt will not represent a public health concern when the product is used according to the label. 

Fluralaner is administered to laying hens and replacement chickens orally via drinking water as 2 single doses, spaced 7 days apart with each dose consumed over a period of 6 to 24 hours. Each dose is 0.5 mg fluralaner/kg (0.227 mg/lb) body weight, equivalent to 0.05 mL of Exzolt/kg body weight (0.023 mL/lb). 

People administering Exzolt should wear protective gloves and take care when handling the product to avoid skin and eye exposure. 

Exzolt is only available by prescription from a licensed veterinarian because professional expertise is required to monitor the safe and effective use of this product. 

The application is sponsored by Intervet, Inc. based in Rahway, New Jersey. 

Source from FDA:https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-oral-product-treatment-and-control-northern-fowl-mites-laying-hens-and

veterinary syringe