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FDA approves generic monensin

Agency reminds users of toxicity for horses.

The U.S. Food & Drug Administration announced July 8 that it has approved the first generic monensin (Monovet 90) for use in cattle and goats for certain indications.

FDA emphasized that while monensin is safe for cattle and goats when fed as directed, it is toxic and potentially lethal to horses at these levels, and overdoses in cattle, goats and other animals have occurred.

FDA said it is also reminding medicated feed mills that they must follow current good manufacturing practices (CGMPs) in 21 C.F.R. Part 225 to help prevent carryover of medicated articles into non-medicated feed. Some firms also are subject to the Food Safety Modernization Act’s Preventative Controls for Animal Food regulation, which requires them to identify likely hazards and develop written plans to control for those hazards.

FDA said Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals and Guidance for Industry #72: GMPs for Medicated Feed Manufacturers Not Required to Register & Be Licensed with FDA are two guidance documents that provide further explanation and examples of how to meet FDA’s requirements for the safe manufacture of animal food.

Horses exposed to monensin may show a range of symptoms, including weakness, unsteady gait, the inability to get up, diarrhea, abdominal pain, excessive urination, heart failure or death, the agency said. Acute toxicity may progress rapidly enough that the horse doesn’t exhibit many symptoms prior to death. Monensin toxicity is rarely treatable, and the majority of horses die or are euthanized to avoid pain and suffering. Horses that survive monensin toxicity may suffer permanent damage to the heart or muscles and are unlikely to fully recover.

FDA said the generic Monovet 90 is approved for use in:

* Cattle fed in confinement for slaughter for: (1) improved feed efficiency and (2) the prevention and control of coccidiosis due to the parasites Eimeria bovis and Eimeria zuernii;

* Dairy cows for increased milk production efficiency;

* Growing cattle on pasture or in dry lots for increased rate of weight gain and for the prevention and control of coccidiosis;

* Mature reproducing beef cows for improved feed efficiency when receiving supplemental feed and for the prevention and control of coccidiosis;

* Calves (excluding veal calves) for the prevention and control of coccidiosis, and

* Goats maintained in confinement for the prevention of coccidiosis caused by the parasites Eimeria crandallis, Eimeria christenseni and Eimeria ninakohlyakimovae.

FDA said Monovet 90 is safe for cows and goats when administered in feed, the meat and milk from cows and goats treated with Monovet 90 are safe for people to consume, the product does not pose any significant impacts to the environment and any risks associated with administering the product can be mitigated by taking appropriate safety precautions, such as wearing protective clothing, impervious gloves and a dust mask.

Monensin is an ionophore, which is an antimicrobial not used in humans and, therefore, does not raise antimicrobial resistance concerns, the agency said.

Monovet 90 is a Type A medicated article and will be available over the counter in 25 kg bags, FDA said, noting that it is approved for use in the manufacture of Type B and Type C medicated feeds. Monovet 90 is manufactured by Huvepharma EOOD.

More information is available in the Freedom of Information Summary for Monovet 90.

Source: Food & Drug Administration, which is solely responsible for the information provided and is wholly owned by the source. Informa Business Media and all its subsidiaries are not responsible for any of the content contained in this information asset.
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