FDA Issues Emergency Use Authorization For Generic Drug To Prevent New World Screwworm In Cattle

(MENAFN- GlobeNewsWire - Nasdaq) Silver Spring, Md., Aug. 27, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Bimectin (ivermectin) injection for the prevention of New World screwworm (NWS) infestations (myiasis) in cattle when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound – advancing the Trump Administration's goal of safeguarding American agriculture from NWS. Bimectin injection is not authorized for use in lactating dairy cows or in calves that will be processed for veal.

“This authorization reflects the FDA's commitment to expanding generic drug options against New World screwworm,” said Timothy Schell, Ph.D., director of the FDA's Center for Veterinary Medicine.“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.”

To maintain the continued safety of the food supply and avoid drug residues, it is critical that cattle producers carefully follow the 35-day slaughter withdrawal time and not administer this drug in lactating dairy cows and calves that will be processed for veal.

Based on the totality of the scientific evidence available, the FDA has concluded it is reasonable to believe that Bimectin injection may be effective for the prevention of NWS myiasis in certain cattle when used as authorized, and the known and potential benefits of the product outweigh its known and potential risks.

Bimectin injection is a generic version of Ivomec, which was authorized in February 2026 for the prevention of NWS myiasis in cattle. The FDA previously approved Bimectin injection for the treatment and control of various parasites in cattle. This EUA is only for the Bimectin injection and does not authorize other dosage forms of Bimectin.

Bimectin injection is available over the counter without a prescription. Cattle producers are responsible for using Bimectin injection in accordance with the product labeling and fact sheet.

This EUA will be effective until it is revoked or the HHS Secretary terminates the declaration that the potential public health emergency presented by NWS justifies the emergency use authorization of animal drugs for NWS.

Bimectin injection is sponsored by Bimeda Animal Health Ltd. based in Ireland.

Related Information:

• Freedom of Information Summary: Bimectin injection (EUA 006729)
• Letter of Authorization: Bimectin injection (EUA 006729)
• Fact Sheet: Emergency Use Authorization of Bimectin (ivermectin) Injection for New World Screwworm (NWS)
• Animal Drugs for New World Screwworm
• Emergency Use Authorization of Animal Drugs for NWS
• Screwworm.gov – Unified Government Response to Protect the United States

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

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