Zoetis Inc. announced that Dectomax/Dectomax®-CA1 (doramectin injection) was recently granted conditional approval of the 100 mL vial size for the prevention and treatment of infestations caused by Cochliomyia hominivorax (New World screwworm) larvae in cattle, and prevention of reinfestation for 21 days.
With previous conditional approval of the 250 mL and 500 mL sizes, Dectomax-CA1 Injectable is now available in all three sizes. Dectomax-CA1 remains the only nonprescription product conditionally approved by the FDA to prevent and treat infestations caused by New World screwworm larvae in cattle.
This conditional approval applies to beef cattle, female dairy cattle less than 20 months of age, pregnant beef cows, newborn calves and bulls. Dectomax-CA1 is not for use in calves to be processed for veal. Dectomax-CA1 is not for use in female dairy cattle 20 months of age or older, except under the conditions of the recently granted Emergency Use Authorization (EUA).
Zoetis has been granted an EUA for use of Dectomax/Dectomax-CA1 in dairy cattle, horses, sheep, pigs and deer. The EUA, issued by the U.S. Food and Drug Administration (FDA), is for the emergency use of the approved/conditionally approved products Dectomax/Dectomax-CA1 for the following indications:
- The prevention and treatment of infestations caused by Cochliomyia hominivorax larvae (myiasis) in dairy cattle (lactating dairy cows with a 468-hour milk withdrawal period, dry dairy cows, and replacement dairy heifers 20 months of age and older), except for calves to be processed for veal.
- The prevention of infestations caused by Cochliomyia hominivorax larvae (myiasis) in swine, sheep except for lactating sheep, and deer.
- The prevention of infestations caused by Cochliomyia hominivorax larvae (myiasis) in horses one year old and older.
This EUA does not provide full or conditional approval but the Center for Veterinary Medicine (CVM) at the FDA has determined Dectomax/Dectomax-CA1 may be effective and safe for indications against NWS in these additional species. To date, there are no animal drugs with a full FDA approval for NWS myiasis.
“We continue to work with CVM to find product solutions that may be safe and effective for use in additional species,” says Mike Lormore, DVM, MS, MBA, Director of Cattle and Pork Technical Services at Zoetis. “The recent conditional approval and emergency use authorization will enable additional producers, veterinarians and animal caretakers to implement prevention and treatment procedures to help protect against New World screwworm.”
For more information on New World screwworm, the current conditional approval and the EUA for Dectomax/Dectomax-CA1, visit zoetisus.com/NewWorldscrewworm.
Dairy Cattle, Swine, Sheep and Deer Fact Sheet
Dectomax-CA1 is conditionally approved by FDA pending a full demonstration of effectiveness under NADA 141-616.
Important Information:
Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
Dectomax-CA1 Injectable (Cattle only), as authorized under the Conditional Approval for use against New World screwworm, has a 35-day pre-slaughter withdrawal period. Do not use in calves to be processed for veal. Do not use in female dairy cattle 20 months of age or older, except under the conditions of the Emergency Use Authorization. Use in dogs may result in fatalities.
Dectomax/Dectomax-CA1 Injectable Emergency Use Authorization, authorized for the duration of the emergency declaration, does not provide full or conditional approval but the Center for Veterinary Medicine (CVM) at the Food and Drug Administration (FDA) has determined that Dectomax/Dectomax-CA1 may be effective and safe. Dectomax/Dectomax-CA1 Injectable, as authorized under the Emergency Use Authorization for use against New World screwworm, has a 35-day pre-slaughter withdrawal period for lactating dairy cattle, dry dairy cattle, replacement dairy heifers, sheep and deer, and a 24-day pre-slaughter withdrawal period for swine. Treated calves and calves born to treated cows should not be processed for veal. Withhold milk from dairy cattle for 468 hours (19.5 days) after treatment has ended. Not for use in lactating sheep. Not for use in horses less than 1 year of age.
About Zoetis
Zoetis is the world’s leading animal health company, driven by a singular purpose: to nurture our world and humankind by advancing care for animals. With a legacy of nearly 75 years, Zoetis continues to pioneer ways to predict, prevent, detect, and treat animal illness, supporting veterinarians, livestock producers, and pet owners in over 100 countries. We integrate deep scientific expertise, data-driven R&D, advanced manufacturing, and commercial excellence to deliver meaningful innovation across medicines, vaccines, diagnostics, biopharmaceuticals, and digital solutions. Guided by our vision to be the most trusted and valued animal health company, Zoetis is committed to setting new standards for the future of animal care through innovation, customer obsession, and purpose-driven colleagues. To learn more, visit Zoetis.com.
