FDA adds new treatment option as screwworm threat nears U.S.
On Monday, the U.S. Food and Drug Administration issued an Emergency Use Authorization for Negasunt Powder (coumaphos, propoxur, and sulfanilamide topical powder) for the prevention and treatment of New World screwworm infestations.
The FDA has concluded that based on the scientific evidence available, it is reasonable to believe that Negasunt Powder may be effective for the prevention and treatment of NWS myiasis in cattle, swine, goats, sheep, horses, donkeys, domestic hybrid equids (e.g., mules), and captive wild, exotic, and zoo mammals, and that the known and potential benefits of the product outweigh its known and potential risks.
Currently, Elanco US Inc., the drug sponsor, intends to limit distribution of Negasunt Powder to the U.S. Department of Agriculture for further distribution to authorized users. Prior to an incursion of NWS into the U.S., Negasunt Powder is only available for use by employees of federal, state, local, and federally recognized tribal agencies, and people working under their authority and at their direction.
If there is an incursion of NWS into the U.S., the product may also be used by or on the order of a licensed veterinarian in NWS-infested zones and adjacent surveillance zones as defined by the USDA in the NWS Response Playbook. There are no NWS-infested zones in the U.S. because, to date, NWS is not currently in the U.S, however, it was most recently detected 60 miles from the Texas border.
Coumaphos and propoxur, two of the active ingredients in Negasunt Powder, can cause neurotoxicity.
The FDA outlined several food safety restrictions tied to the emergency authorization. Treated animals cannot be slaughtered for human consumption within 28 days of the last application, and the product is not approved for use in animals producing milk for human consumption, as no milk withdrawal period has been established. Additionally, pre-ruminating calves, including those born to treated cows, must not be processed for veal due to the lack of an established withdrawal period.
The authorization will remain in effect until it is revoked or until federal health officials determine that the potential public health threat posed by New World screwworm no longer justifies emergency use of these animal drugs.
Earlier this month, the FDA also issued emergency use authorizations for four other animal drugs aimed at preventing and treating screwworm. The authorizations include three products from Boehringer Ingelheim Animal Health USA: Ivomec (ivermectin), NexGard (afoxolaner), and NexGard Combo, along with an antiseptic wound spray with insecticide from Health and Hygiene Ltd.
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