FDA Conditionally Approves First Drug for Prevention and Treatment of New World Screwworm Infestations in Cattle
Sourse: dairynews.today
The FDA has conditionally approved Dectomax-CA1, an injectable solution, for treating New World screwworm infestations in cattle, highlighting a pivotal step in safeguarding livestock.
On September 30, 2025, the U.S. Food and Drug Administration granted conditional approval to Dectomax-CA1 (doramectin injection), marking the first conditional approval in the U.S. for a treatment targeting New World screwworm (NWS) infestations. This decision underscores the FDA's commitment to expediting animal medicine approvals crucial for the livestock industry.
"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."
Dectomax-CA1 is designed to prevent and treat serious threats in cattle, addressing unmet health needs and circumventing complex efficacy studies. The FDA confirms the safety and reasonable efficacy expectation of the drug, available immediately for cattle producers while further data is collected for full approval.
Timothy Schell, acting director of the FDA’s Center for Veterinary Medicine, stated, "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."
Dectomax-CA1 shares its active ingredient with the fully approved Dectomax, known for treating nematode and arthropod parasites in cattle and swine. The withdrawal and safety protocols remain consistent between the two. The FDA warns that a withdrawal period has not been established for pre-ruminating calves and advises specific usage to mitigate antiparasitic resistance.
Dectomax-CA1, produced by Zoetis in Kalamazoo, Michigan, is vital for livestock health and economic stability, paving the way for greater preventive measures in cattle against screwworm infestations.
"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."
Dectomax-CA1 is designed to prevent and treat serious threats in cattle, addressing unmet health needs and circumventing complex efficacy studies. The FDA confirms the safety and reasonable efficacy expectation of the drug, available immediately for cattle producers while further data is collected for full approval.
Timothy Schell, acting director of the FDA’s Center for Veterinary Medicine, stated, "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."
Dectomax-CA1 shares its active ingredient with the fully approved Dectomax, known for treating nematode and arthropod parasites in cattle and swine. The withdrawal and safety protocols remain consistent between the two. The FDA warns that a withdrawal period has not been established for pre-ruminating calves and advises specific usage to mitigate antiparasitic resistance.
Dectomax-CA1, produced by Zoetis in Kalamazoo, Michigan, is vital for livestock health and economic stability, paving the way for greater preventive measures in cattle against screwworm infestations.
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