FDA批准用于预防螺旋蝇的仿制药伊维菌素注射剂
FDA Authorizes Generic Ivermectin Shot To Prevent Screwworm

原始链接: https://www.zerohedge.com/medical/fda-authorizes-generic-ivermectin-shot-prevent-screwworm

美国食品药品监督管理局(FDA)已授予通用名伊维菌素注射液 Bimectin 紧急使用授权,用于预防牛群感染新世界螺旋蝇蛆病。该药由 Bimeda Animal Health 生产,获批用于出生 24 小时内的小牛,以及阉割或有伤口时的牛只。严禁用于泌乳期的奶牛或旨在生产小牛肉的牛犊。 FDA 官员根据巴西和阿根廷的成功研究结果得出结论,认为该药物在预防螺旋蝇蛆感染方面的潜在益处大于风险。此次授权是在美国近期出现大量新世界螺旋蝇蛆病例(尤其是在得克萨斯州)之后做出的。通过批准这种 Ivomec 的通用替代品,FDA 旨在确保畜牧生产者拥有可靠且多样化的选择,以保护其牛群免受这种食肉害虫的侵害。此举是联邦政府为应对近期螺旋蝇蛆疫情而授权十多种动物药物的更广泛举措的一部分。

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原文

Authored by Zachary Stieber via The Epoch Times,

Federal regulators have authorized a generic ivermectin injection for the prevention of New World screwworm in cattle.

The Food and Drug Administration on Aug. 27 granted emergency use authorization for Bimectin, the injection, for use within 24 hours of birth.

The drug can also be used when castration is performed, or when a wound appears. It cannot be used in lactating dairy cows or in calves destined for veal.

Bimectin is a generic version of Ivomec, which the FDA authorized in February. The FDA previously approved Bimectin for treating and controlling parasites in cattle. The application for Bimectin came from Bimeda Animal Health, an Ireland-based company.

Based on available evidence, FDA officials concluded that the injection may prevent screwworm in cattle, and that the known and potential benefits outweigh known and potential risks. That information includes studies carried out in Brazil and Argentina in the 1990s, and a 2019 study conducted in Brazil, which found ivermectin injection prevented screwworm infestations in cattle, according to an FDA fact sheet.

"The animal safety profile for cattle, including male and female reproducing cattle, is well-characterized, and the information provided support that the food products obtained from the treated animals are safe for human consumption when used under the conditions described in the authorization," the fact sheet stated.

"This authorization reflects the FDA's commitment to expanding generic drug options against New World screwworm," Timothy Schell, director of the FDA's Center for Veterinary Medicine, said in a statement. "By authorizing both generic and pioneer products, the Agency is ensuring producers aren't dependent on a single manufacturer or product to protect their herds."

Ivermectin is an antiparasitic medication widely used in animals. The drug is also available for humans, primarily to prevent worm infections.

Screwworm, a flesh-eating pest, entered the United States from Mexico earlier in 2026 for the first time in years.

The Trump administration has since approved or authorized more than a dozen drugs for screwworm prevention and/or treatment, including an ivermectin oral solution for horses, a medication for dogs and puppies, and a generic treatment for dogs, puppies, cats, and kittens.

The U.S. Department of Agriculture, in its latest update, with data current through Aug. 25, said that there have been three screwworm cases in August, all in Texas. Two of the cases were among sheep, and one was in a goat.

There were 14 cases in July and 30 in June.

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