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2500 Innovation Way
Greenfield, IN 46140 USA

1-877-ELANCO1

(1-877-352-6261)

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07-Nov-2018

FDA Approves Elanco’s Experior

Post by: Keri McGrath

First animal drug that reduces ammonia gas emissions from an animal or its waste

GREENFIELD, IND. (November 7, 2018) – Today, Elanco Animal Health Incorporated (NYSE: ELAN) announced that a first-of-its-kind, medicated feed article, Experior™ (Lubabegron), was granted approval by the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM). It was approved for the reduction of ammonia gas emissions per pound of live weight and hot carcass weight in cattle during the last 14 to 91 days on feed. FDA’s news release on the approval can be viewed here.  

“Elanco is proud of this pioneering effort to address key customer needs to help reduce environmental impact,” said Aaron Schacht, executive vice president, Innovation, Regulatory and Business Development of Elanco Animal Health. “This innovation is an important new tool that should enable beef producers to care for their cattle and the environment.”

 

Elanco is committed to providing One Health-focused innovations – such as Experior - that support the industry’s environmental sustainability efforts.*

 

We recognize the impact animal health has on the health of people and the planet. One Health is the ecosystem in which healthy animals, healthy people and a healthy environment work in balance for a healthier world, and is the lens through which Elanco views innovation. To achieve a future where everyone can live and thrive, science must make progress on three aspects of global health: healthy animals, people, and planet. Elanco believes it starts with animals.

 

*Ammonia gas emissions were measured for individual animals or small groups of animals held in environmentally controlled facilities. Based on existing information, reliable predictions of the reduction of ammonia gas emissions cannot be made on a herd, farm, or larger scale.

 

About Experior (lubabegron Type A medicated article)

Caution: Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing Experior. A decrease in dry matter intake may be noticed in some animals.

 

The label contains complete use information, including cautions and warnings. Always read, understand, and follow the label, and use directions.  

Directions for Use: Feed 1.25 to 4.54 g/ton (1.39 to 5 ppm) of complete feed (90% dry matter basis) to provide 13-90 mg lubabegron/head/day continuously to beef steers and heifers fed in confinement for slaughter as the sole ration during the last 14 to 91 days on feed.

   

About Elanco
Founded in 1954, Elanco provides comprehensive products and knowledge services to improve animal health and food-animal production in more than 90 countries around the world. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 5,800 employees worldwide. Together with our customers, we are committed to raising awareness about global food security, and celebrating and supporting the human-animal bond. Our worldwide headquarters and research facilities are located in Greenfield, Indiana.

 

Forward-Looking Statement
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Experior for the reduction of ammonia gas emissions per pound of live weight and hot carcass weight in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed and reflects Elanco’s current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that Experior will be commercially successful. For further discussion of these and other risks and uncertainties, see Elanco’s most recent filings with the United States Securities and Exchange Commission. Except as required by law, Elanco undertakes no duty to update forward-looking statements to reflect events after the date of this release.

  

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Experior, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. ©2018 Elanco or its affiliates. US-PM-18-0367

Media Contact:
Keri McGrath
(317) 370-8394
mcgrath_happeks@elanco.com

Investors Contact:
Jim Greffet
(317) 383-9935

General Inquiries

Elanco Animal Health
2500 Innovation Way
Greenfield, IN 46140 USA

1-877-ELANCO1

(1-877-352-6261)

Media Contacts

Questions?
Contact us.



Our Global Offices

Follow Elanco

About Elanco

Elanco (NYSE: ELAN) is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.