November 3, 2004
FDA Approves Rumensin® for Increased Milk Production Efficiency in Dairy Cows
The U.S. Food and Drug Administration has approved Rumensin® (monensin sodium) for increased milk production efficiency in dairy cows.
Rumensin®, a product of Elanco Animal Health, a division of Eli Lilly and Company, Greenfield, Indiana, is already approved in feed for therapeutic and production uses in feedlot cattle, pasture cattle (beef and dairy heifers, and slaughter, stocker feeder cattle), beef cows, and calves excluding veal calves.
Rumensin® is the first, approved new animal drug feed ingredient for dairy cows that increases milk-production efficiency. FDA reviewed extensive data to ensure the product met all necessary efficacy, animal health, human food safety, and environmental standards. FDA has concluded that the meat and milk derived from dairy animals fed monensin sodium are safe when the animals are fed according to the approved labeling.
Previous caution statements on the label will remain including the caution not to feed to horses or other equines as ingestion of monensin sodium by horses has been fatal.
FDA's approval of Rumensin® for use in feed for lactating dairy cattle constitutes a safe use of monensin sodium when used according to the approved label. As a feed additive, extra-label or off label use of monensin sodium is illegal and is not permitted under the Animal Medicinal Drug Use Clarification Act.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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