A close-up image of a New World screwworm larva.
U.S. Department of Agriculture’s Agricultural Research Service
“We understand the urgency with which America’s farmers and ranchers are asking for tools to fight New World screwworm,” said FDA Commissioner Marty Makary. “Today’s conditional approval—the first in the U.S. for NWS—shows our dedication to rapidly advancing important animal medicines when they are needed most.
“We continue to work tirelessly to complete review of other NWS products to protect multiple animal species in the U.S.,” Makary said. Dectomax-CA1 is conditionally approved for use only in cattle.
The drug is eligible for conditional approval because its use is intended to prevent and treat a serious or life-threatening disease, it addresses an unmet animal health need and demonstrating its effectiveness would require complex or difficult studies.
Dectomax is already fully approved under a New Animal Drug Application for treatment and control of some nematode and arthropod parasites in cattle and swine. Dectomax and Dectomax-CA1 contain the same active ingredient (doramectin injection) at the same dose. Because Dectomax’s approval required studies and additional information, FDA did not require new information for the conditional use of Dectomax-CA1.
“Under this conditional approval, the FDA has determined the drug is safe and has a reasonable expectation of effectiveness,” said Timothy Schell, acting director of the FDA’s Center for Veterinary Medicine.
The withdrawal period for Dectomac-CA1 is 35 days. The drug should not be used in female dairy cattle 20 months of age or older, or in calves to be processed for veal. The FDA encourages producers and veterinarians to use Dectomax-CA1 only when medically necessary to reduce the risk of antiparasitic resistance.
Dectomax-CA1 is manufactured by Zoetis Inc.
USDA update
Speaking at the Agriculture Outlook Forum in Kansas City, MO, in late September, USDA Secretary Brooke Rollins shared more details about the latest detection of NWS in Mexico.
“Unfortunately, what we found was Mexico has failed to enforce proper cattle movement controls infected regions and is not tending to fly traps daily as promised, which hinder our real time detection capabilities,” Rollins said.
She said Mexico must implement the agreed-upon protocols, expand survelliance immediately and lock down cattle movement in infected areas. Until 100% compliance is demonstrated, Rollins said, a border reopening plan will not be considered
