Conditional Approval Allows Use for NWS Fight
FDA Approves Dectomax for Prevention and Treatment of NWS in US
OMAHA (DTN) -- The U.S. Food and Drug Administration conditionally approved the first injectable solution for the prevention and treatment of New World screwworm (NWS) in cattle on Tuesday, Sept. 30.
"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. "This conditional approval -- the first in the U.S. for NWS -- shows our dedication to rapidly advancing important animal medicines when they are needed most."
The product, Dectomax-CA1 (doramectin injection), was approved for the prevention and treatment of screwworm larval infestations in cattle, as well as the prevention of reinfestation for 21 days. This conditional approval was a crucial step forward, as the FDA recognized the pressing need for effective solutions to protect the nation's livestock.
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"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. "We are making this treatment available to cattle producers immediately while the sponsor collects the data needed for a full approval."
For Mike Lormore, director of Cattle and Pork Technical Services at Zoetis, the pharmaceutical company behind the product, this approval was a significant milestone in the fight against NWS.
"New World screwworm has the potential to bring unprecedented economic and animal health harm to livestock producers," Lormore said. "Our top priority is to support keeping animals healthy and provide timely, efficacious solutions to our customers and partners. With this conditional approval, Dectomax-CA1 Injectable can now be used as part of safe, effective control measures against New World screwworm."
Livestock producers are encouraged to work closely with their herd veterinarians to implement strategic prevention and control measures using Dectomax-CA1. Early detection and rapid response are critical to protecting the health of animals and the livestock industry.
Producers are encouraged to immediately report any suspicious wounds, maggots, or infestations to their local accredited veterinarian, state animal health official or the U.S. Department of Agriculture's Animal and Plant Health Inspection Service.
With the arrival of Dectomax-CA1, farmers and ranchers across the country have a new weapon to combat NWS.
"We continue to work tirelessly to complete review of other NWS products to protect multiple animal species in the U.S.," said Makary.
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Editor's note: This content was supplied by the Food and Drug Administration and Zoetis and edited by DTN using artificial intelligence.
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