Today, the U.S. Food and Drug Administration conditionally approved Exzolt Cattle-CA1 (fluralaner) topical solution for the prevention and treatment of New World screwworm (NWS) larval infestations, and the treatment and control of cattle fever tick in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age.
This conditional approval means the FDA has determined Exzolt Cattle-CA1 is safe and has a reasonable expectation of effectiveness for its intended use. The sponsor, Intervet, Inc. of Rahway, New Jersey, has up to five years to generate the additional effectiveness data needed to support a full FDA approval.