November 6, 2018
“We’re committed to supporting the development of novel animal drug products that are safe and effective, and we’re encouraged to see innovations that provide additional benefits to animals, people and the environment,” said Steven M. Solomon, M.P.H., D.V.M., director of the FDA’s Center for Veterinary Medicine. “Today we’re announcing the approval of the first animal drug that reduces ammonia gas emissions from an animal or its waste. These ammonia gasses can come from many sources and can affect the health of people, animals and the environment. Novel animal drug products such as these also support One Health approaches to public health.”
The U.S. Food and Drug Administration announced today the approval of Experior (lubabegron Type A medicated article), the first animal drug that when fed to beef cattle under specific conditions results in less ammonia gas released as a by-product of their waste.
Ammonia gas emissions can come from many sources, including the manure of beef cattle. Ammonia gas emissions are a concern because they have been implicated in atmospheric haze and noxious odors. High concentrations of ammonia can cause irritation of the eyes, nose and throat in both humans and animals. Additionally, ammonia gases can contribute to a process called eutrophication, in which bodies of water become enriched with excess nutrients, especially nitrogen and phosphorous. This nutrient enrichment in the water causes algae blooms, which block sunlight to aquatic plants, and eventually results in the death of aquatic animals due to a lack of oxygen in the water.
Studies of Experior indicated that the product partially reduces ammonia gas emissions from manure from an individual animal or a pen of animals in semi-controlled conditions in enclosed housing. However, the studies did not measure ammonia gas emissions on a herd or farm scale.
Multiple studies showed that Experior is safe to feed to beef cattle and that meat from cattle treated with Experior is safe for people to eat. More than 4,000 cattle were studied, and the results showed a low incidence of health issues overall, and no difference between control animals and those receiving Experior.
In a simultaneous yet separate review, the Veterinary Drugs Directorate (VDD) of Health Canada has also reviewed Experior. This underscores the continued collaboration between the FDA’s Center for Veterinary Medicine and VDD, aimed at facilitating access to veterinary drugs across both countries.
The One Health Initiative recognizes that the health of people, animals, and the environment is intertwined. The Initiative advocates for a comprehensive approach to health and environmental problems and aims to promote, improve, and defend the health and well-being of all species.
The FDA granted approval of Experior to Elanco.
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, products that give off electronic radiation, and for regulating tobacco products.