FDA approves generic monensin

Agency reminds users of toxicity for horses.


Source: Food & Drug Administration

via Feedstuffs - Jul 08, 2019


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 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:


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