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Comprehensive, multi-year evaluation by the EPA, with assistance from the Food and Drug Administration, verifies Seresto continues to satisfy EPA requirements for item registration
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Data verifies the safety profile of the item
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Expert toxicologists and vets voice their assistance of Seresto’s safety profile
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Elanco and EPA create stewardship program anticipated to raise the bar for the flea and tick collar classification
GREENFIELD, Ind., July 13, 2023–(BUSINESS WIRE)–Elanco Animal Health Incorporated (NYSE: ELAN) and the U. S. Environmental Protection Agency (EPA) today revealed that EPA, with assistance from the Food and Drug Administration (FDA), has actually finished its extensive, multi-year evaluation of the Seresto® flea and tick collar. EPA verifies continued registration of the collar. Comprehensive information verifies the safety profile of Seresto.
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As part of EPA’s clinical evaluation procedure, the firm evaluated event information consisting of third-party evaluations and compared information to other EPA-registered animal items. EPA’s conclusions discovered that the most often reported occurrences were mainly dermatologic in nature, such as itching or soreness around the collar website, which follows previous findings. According to EPA, Seresto continues to satisfy all of EPA’s requirements for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which guarantees that items do not posture unreasonable danger of damage.
Following the extensive evaluation, Elanco and EPA established a stewardship program that Elanco will carry out as a leader in the collar classification. The program consists of:
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Enhanced information collection for unfavorable occasion (AE) reports
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Continued yearly improved reporting of Seresto AE information, comparable to what EPA needs for animal spot-on items
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Outreach to the veterinary neighborhood
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Review of the collar release system
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Separation of item registrations for dog and cat
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Updates to package insert language
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Five-year registration evaluation to guarantee stewardship program actions support the ongoing safe usage of Seresto. Elanco will finish a renewal procedure near completion of this duration.
Elanco motivates EPA to carry out these steps as a brand-new EPA requirement throughout all flea and tick collars to guarantee constant expectations for reporting throughout the classification, comparable to the raised requirements the firm executed in 2010 for animal spot-on pesticide items (items used straight to the skin of animals for flea and tick control).
Since launch in 2013, more than 41 million Seresto collars have actually been offered in the U.S. Over this duration, the reporting rate for all occurrences associated with Seresto has actually been low and trending downward. In 2022, the approximated occurrence of unfavorable occasions in the U.S. following direct exposure to Seresto was roughly 0.116%, which relates to roughly 1 animal with a reported unfavorable occasion for every single 1,000 collars dispersed in the U.S., most of which connect to non-serious occasions such as itching or soreness localized at the collar application website.
The EPA’s conclusions line up with those of authorities worldwide, with Seresto being authorized for usage in more than 80 nations and supported by veterinary specialists around the world. The robust clinical proof – information produced prior to approval through present day, consisting of continuous post-market monitoring information, and broad usage of more than 110 million collars around the globe – more assistances Seresto’s safe usage.
“We value EPA’s diligence throughout this data-driven evaluation procedure, leading to a clear result and continued item schedule to secure animals and human health,” said Dr. Ellen de Brabander, Executive Vice President of Innovation and Regulatory Affairs at Elanco. “We back up more than a years of science-based information, analysis and tracking which verifies the safety profile of Seresto. As a leader in animal health, we are dedicated to the wellness of animals and invite the chance to deal with EPA to carry out these stewardship actions. We anticipate these actions to raise the bar for flea and tick collars and support the ongoing safe usage of Seresto to secure animals from fleas and ticks and the lethal illness they bring.”
According to the Center for Disease Control and Prevention (CDC), tickborne illness cases have actually increased 25% from 2011 to 2019.i The Companion Animal Parasite Council (CAPC) suggests avoiding contact in between animals and parasites by utilizing items that eliminate and/or fend off ticks.ii
Veterinary and Toxicology Experts Voice Their Support for Seresto
Veterinary and toxicology specialists around the nation have actually been singing in their assistance of Seresto. With the EPA evaluation total, specialists share their thanks for offering animal owners the closure and self-confidence they require throughout what has actually begun as a much heavier than typical flea and tick season.
“Our Pet Poison Helpline information and experience supports the total safety profile of Seresto. The health care these collars supply by safeguarding animals from harmful illness that fleas and ticks bring far surpass the incredibly unusual danger of a major unfavorable occasion,” says Dr. Ahna Brutlag, Veterinary Toxicology Expert from Pet Poison Helpline, a nationwide animal toxin nerve center.
In-center vets likewise continue to voice their assistance of Seresto as a hassle-free, reliable and inexpensive choice for customers.
“This conclusion from EPA comes at a vital time as animal owners require to be considering safeguarding their animals from insects throughout this heavy flea and tick season. As a vet and animal owner myself, I understand the value of safeguarding both animals and human beings from threats connected with fleas and ticks,” said Dr. Lisa Lippman, practicing veterinarian. “With the Seresto collar, the considerable body of clinical proof continues to support its strong safety profile and efficiency to supply 8 constant months of security versus fleas and ticks which can send harmful illness, such as Lyme illness. Seresto provides a much-needed, cost-reliable choice for security. That’s why I completely support and utilize Seresto and advise it to animal owners for use year-round.”
Numerous research studies and event information analyses have actually concluded that Seresto has a strong safety profile and does not posture an unreasonable danger, which is why the American Veterinary Medical Association has actually revealed assistance for Seresto’s continued EPA registration.
ABOUT ELANCO
Elanco Animal Health (NYSE: ELAN) is an international leader in animal health committed to innovating and providing services and products to avoid and treat illness in stock and animals, producing worth for farmers, animal owners, vets, stakeholders, and society as a whole. With almost 70 years of animal health heritage, we are dedicated to assisting our consumers enhance the health of animals in their care, while likewise making a significant influence on our regional and worldwide neighborhoods. At Elanco, we’re driven by our vision of Food and Companionship Enriching Life and our technique to sustainability, Elanco Healthy Purpose™– all to advance the health of animals, individuals, the world and our enterprise. Learn more at www.elanco.com.
i Trends in Reported Babesiosis Cases — United States, 2011–2019 | MMWR (cdc.gov)
ii Companion Animal Parasite Council | 2023 Annual Pet Parasite Forecasts (capcvet.org)
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Contacts
Media: Season Solorio (765) 316-0233 [email protected]
Investor: Kathryn Grissom (317) 273-9284 [email protected]
