The FDA announced today that it has conditionally approved fluralaner topical solution (Exzolt Cattle-CA1; Intervet Inc.), for preventing and treating New World Screwworm (NWS) larval infestations. The product is also indicated for treating and controlling cattle fever tick in beef cattle over 2 months of age, and replacement dairy heifers that are less than 20 months old.
By receiving conditional approval, fluralaner topical solution was determined by the FDA to be safe and have a reasonable expectation of effectiveness for its intended use. The product's sponsor, Intervet Inc., from Rahway, New Jersey, also has up to 5 years to now generate the additional effectiveness data the FDA needs to support a full approval.
“The FDA is leveraging every resource and authority at its disposal to ensure producers and veterinarians have the critical products they need to protect their livestock and safeguard our food supply against NWS and cattle fever tick,” Timothy Schell, PhD, director of the FDA’s Center for Veterinary Medicine, said in an organizational release.1 “We remain steadfast in our commitment to ensuring that animal drugs are safe and effective and that food from treated animals is safe to eat.”
Per FDA standards, fluralaner topical solution became eligible for conditional approval because it is intended to prevent and treat a serious or life-threatening illness in cattle, demonstrated effective of the drug requires complex or particularly difficult studies, and addressed an unmet animal health need. The treatment also received an expedited review through a priority zoonotic animal designation, which is authority given to the FDA under the Coronavirus Aid, Relief, and Economic Security Act.
The slaughter withdrawal period for fluralaner topical solution is 98 days to prevent unsafe drug residues in meat from treatment cattle as well as ensure human food safety.1 The FDA also stated that this product is not for use in lactating dairy cattle, dairy calves, veal calves, or bulls who are at least 1 year old and intended for breeding.
“This conditional approval gives cattle producers a new tool to combat two parasites threatening the well-being of cattle in the U.S.,” Marty Makary, MD, MPH, FDA Commissioner, said.1 “Although NWS has not been detected in the U.S., cattle fever tick is here. This is the first drug conditionally approved by the FDA specifically for the control and treatment of cattle fever tick.”
Intervet's fluralaner topical solution is only available by prescription and available in 250 mL, 1L, and 5L bottles. The product is single-use, ready-to-use product and is applied directly to the hair and skin in a narrow strip extending along the patient’s back from between the shoulder blades to the base of its tail.
