FDA Issues First ANADA (Generic) Injectable Cattle Dewormer Emergency Use Authorization to Bimeda For Use of Bimeda- Manufactured Ivermectin 1% Injection Products for Prevention of New World Screwworm (NWS)

Schaumburg, IL – August 27, 2026 – Bimeda^®, a global leader in animal health solutions, announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the use of Bimeda-manufactured ivermectin 1% injection products (ANADA# 200-447) for the prevention of infestations caused by New World screwworm (NWS), Cochliomyia hominivorax, in cattle. This EUA includes Bimectin^® (ivermectin) 1% Injection and distributor-labeled bioequivalent products with ANADA# 200- 447 approval.

NWS is a parasitic fly that lays eggs in and on open wounds and mucous membranes of warm-blooded animals. NWS larvae (maggots) burrow into and feed on the living tissue which causes serious tissue damage and potentially fatal infestations¹.

This EUA for Bimeda-manufactured ivermectin 1% injection is authorized for the prevention of infestations caused by NWS larvae (myiasis) when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound in cattle, except for female dairy cattle producing milk for human consumption and calves that will be processed for veal.

"This EUA reflects months of dedicated work by our regulatory team to secure expanded access to Bimectin (ivermectin) 1% Injection for screwworm prevention in cattle. This is the first ANADA (generic) injectable cattle dewormer to be granted an EUA for NWS, " said Dr. Eric Moore, DVM, Technical Veterinarian at Bimeda. "We're proud to offer producers and veterinarians a trusted, over-the-counter ivermectin injection in the same label formats they've relied on for years — now at a more affordable cost and with wider availability when protecting cattle against New World screwworm matters most."

Bimeda-manufactured ivermectin 1% injection (ANADA# 200-447) is authorized for this use only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Bimeda-manufactured ivermectin 1% injection (ANADA# 200-447) under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

For more information, please visit BimedaUS.com/BimectinInj/EUA

IMPORTANT SAFETY INFORMATION - Bimectin® (ivermectin) 1% Injection
Do not treat cattle within 35 days of slaughter. Do not use in female dairy cattle of breeding age or in veal calves. Do not treat swine within 18 days of slaughter. Do not use in other animal species not on the label, as severe adverse reactions, including fatalities in dogs, may result.

References

¹ U.S. Food and Drug Administration. https://www.fda.gov/animal-veterinary/safety- health/animal-drugs-new-world-screwworm. Accessed 8/4/2026