Elanco Expands Initiative to Educate Veterinarians and Pet Owners Post FDA Warning
In a recent announcement, Elanco Animal Health Incorporated reaffirmed its dedication to providing clear and comprehensive education for both veterinarians and pet owners. This commitment comes in the wake of a warning letter issued by the U.S. Food and Drug Administration (FDA), addressing concerns related to promotional practices for one of its products, Zenrelia™ (ilunocitinib tablets).
Elanco has long prioritized the health and well-being of pets and is now focusing on enhancing communication to ensure that both pet owners and veterinarians are adequately informed about their products. The company aims to help pets lead healthier, more active lives by providing innovative solutions and clear guidelines on how to use these products safely and effectively.
Following the FDA's warning, which highlighted misleading claims found in promotional material, Elanco has taken steps to rectify the situation quickly. Importantly, the company clarified that the issues raised do not pertain to the actual use of Zenrelia in the market, as feedback from pet owners has been overwhelmingly positive regarding the product's real-world efficacy.
The FDA issues warning letters to notify companies when they have potentially violated regulations and provides them with an opportunity to respond and correct misleading information. Elanco acknowledged the FDA’s concerns and expressed appreciation for their guidance, reiterating that it is actively reviewing and updating its promotional content for Zenrelia. This product is designed for dogs over the age of 12 months suffering from skin allergies, specifically focusing on controlling itching and inflammation.
The company expects that the adjustments resulting from the FDA warning will not significantly impact Zenrelia's revenue. Elanco remains optimistic about its growth trajectory, projecting an increase in organic constant currency revenue in the mid-single digits for 2025.
Elanco emphasized that it will not only meet FDA requirements but also aims to proactively support veterinarians in providing optimal care for pets. Zenrelia's prescribing information, which includes crucial safety information and a boxed warning regarding vaccine-induced disease risks, will be made accessible and clearer to ensure all stakeholders are well-informed.
Pet owners are encouraged to always discuss any concerns regarding their pets' care with their veterinarians, especially when considering new medications. In the case of Zenrelia, pets must not be vaccinated while on the medication and should be up to date on vaccinations before starting treatment.
Elanco Animal Health has been a global leader in the animal health industry for decades, committed to innovating and delivering products that prevent and treat diseases in pets and livestock alike. Their mission focuses on enriching the lives of both animals and humans and making a positive impact on communities worldwide.
As part of its sustainable practices, Elanco actively works to educate pet owners and veterinarians about safe medication use while emphasizing the health of the pets entrusted to their care. To learn more about Zenrelia and its prescribing guidelines, individuals can visit Elanco’s official website or consult their veterinarian.
In conclusion, Elanco is committed to transparency and compliance moving forward. Through close collaboration with the FDA and dedication to thorough education, they strive to ensure that both pet owners and veterinarians have the resources needed to make informed decisions regarding pet health. This initiative is crucial in maintaining trust and effectiveness in the veterinary field, ultimately leading to healthier pets and happier families.
Understanding Elanco's Commitment
Elanco has long prioritized the health and well-being of pets and is now focusing on enhancing communication to ensure that both pet owners and veterinarians are adequately informed about their products. The company aims to help pets lead healthier, more active lives by providing innovative solutions and clear guidelines on how to use these products safely and effectively.
Following the FDA's warning, which highlighted misleading claims found in promotional material, Elanco has taken steps to rectify the situation quickly. Importantly, the company clarified that the issues raised do not pertain to the actual use of Zenrelia in the market, as feedback from pet owners has been overwhelmingly positive regarding the product's real-world efficacy.
The FDA Warning and Its Implications
The FDA issues warning letters to notify companies when they have potentially violated regulations and provides them with an opportunity to respond and correct misleading information. Elanco acknowledged the FDA’s concerns and expressed appreciation for their guidance, reiterating that it is actively reviewing and updating its promotional content for Zenrelia. This product is designed for dogs over the age of 12 months suffering from skin allergies, specifically focusing on controlling itching and inflammation.
The company expects that the adjustments resulting from the FDA warning will not significantly impact Zenrelia's revenue. Elanco remains optimistic about its growth trajectory, projecting an increase in organic constant currency revenue in the mid-single digits for 2025.
Implications for Pet Owners and Veterinarians
Elanco emphasized that it will not only meet FDA requirements but also aims to proactively support veterinarians in providing optimal care for pets. Zenrelia's prescribing information, which includes crucial safety information and a boxed warning regarding vaccine-induced disease risks, will be made accessible and clearer to ensure all stakeholders are well-informed.
Pet owners are encouraged to always discuss any concerns regarding their pets' care with their veterinarians, especially when considering new medications. In the case of Zenrelia, pets must not be vaccinated while on the medication and should be up to date on vaccinations before starting treatment.
About Elanco Animal Health
Elanco Animal Health has been a global leader in the animal health industry for decades, committed to innovating and delivering products that prevent and treat diseases in pets and livestock alike. Their mission focuses on enriching the lives of both animals and humans and making a positive impact on communities worldwide.
As part of its sustainable practices, Elanco actively works to educate pet owners and veterinarians about safe medication use while emphasizing the health of the pets entrusted to their care. To learn more about Zenrelia and its prescribing guidelines, individuals can visit Elanco’s official website or consult their veterinarian.
In conclusion, Elanco is committed to transparency and compliance moving forward. Through close collaboration with the FDA and dedication to thorough education, they strive to ensure that both pet owners and veterinarians have the resources needed to make informed decisions regarding pet health. This initiative is crucial in maintaining trust and effectiveness in the veterinary field, ultimately leading to healthier pets and happier families.
Topics Health）
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