FDA grants conditional approval for New World screwworm drug
On Sept. 30, the U.S. Food and Drug Administration conditionally approved the first injectable drug for the prevention and treatment of New World screwworm in cattle. The drug is produced by Zoetis and is called Dextomax-CA1 injectable solution.
It was eligible for conditional, limited approval because there was previously no drug treatment for NWS infestation available and the early tests for Dextomax-CA1 showed evidence the drug could successfully treat NWS. The FDA also labeled the drug as providing reinfestation prevention for 21 days.
“Under this conditional approval, the FDA has determined the drug is safe and has a reasonable expectation of effectiveness,” said Timothy Schell, Ph.D., 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. The FDA will continue to expedite review of animal drugs to help the U.S. fight this devastating threat to our nation’s livestock and the livelihoods of the farmers and ranchers who care for them.”
Another drug known as Dectomax, which shares the same active ingredient as Dectomax-CA1—doramectin—has already been approved under a new animal drug application for treatment and control of certain nematode and arthropod parasites in cattle and swine. The earlier approval of Dextomax helped Dectomax-CA1 bypass some of the supporting information the FDA requires for conditional approval.
The withdrawal period for cattle that are administered Dectomax-CA1 is 35 days, and it is not for use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in pre-ruminating calves. Dectomax-CA1 is not for use in calves to be processed for veal. The drug is currently available in 250 and 500 milliliter bottles.
“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, M.D., M.P.H. “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.”
The FDA and U.S. Department of Agriculture have vowed to continue their efforts for a long-term control of NWS, protecting the Southern border and finding additional medical treatments for infestation.
Lacey Vilhauer can be reached at 620-227-1871 or [email protected].
