U.S. FDA Approves New Indication for Merck Animal Health’s Bravecto® (fluralaner topical solution) for Cats and Bravecto® Plus (fluralaner and moxidectin topical solution) for Cats
Single dose topical treatments are the first and only U.S. products to treat and control Asian longhorned (Haemaphysalis longicornis) ticks in felines
MADISON, N.J., September 6, 2022 – Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced the new label indication for both Bravecto® and Bravecto® Plus for the topical use in cats for the treatment and control of Asian longhorned tick infestations. Bravecto and Bravecto Plus for cats are the first and only U.S. products labeled for both the treatment and control of Asian longhorned tick infestations.
The Asian longhorned tick is an invasive Ixodid tick that is native to Japan, China, eastern Russia, and Korea. As of December 2021, the species has been located across more than one-third of the United States. These ticks have the potential to quickly become an important tick species within pet populations and are known for carrying various viral, bacterial, and protozoal agents.
“We’re committed to protecting pets and pet owners alike from parasites that pose risks to both animal and human health. With the new Bravecto and Bravecto Plus indication, we can expand our ability to care for pets by offering an even broader range of parasite protection for cats,” said Dominique Sims, DVM, associate director, scientific affairs, Merck Animal Health. “Veterinarians can now recommend a treatment option that provides more versatile protection than traditional flea and tick offerings, while giving cat owners peace of mind in knowing their pet is safe from infestations.”
The new indication adds to the already high level of protection provided by the topical treatments. Bravecto Topical Solution for Cats is indicated for all the following therapeutic areas:
Treatment and prevention of flea infestations
Treatment and control of black-legged ticks and Asian longhorned tick infestations for 12 weeks
Treatment and control of American dog tick infestations for 8 weeks
In addition, Bravecto Plus for Cats is indicated for all the following therapeutic areas:
Prevention of heartworm disease caused by Dirofilaria immitis
Treatment of infections with intestinal roundworm and hookworm
Ability to kill adult fleas and indicated for the treatment and prevention of flea infestations for two months
Treatment and control of tick infestations of black-legged ticks, American dog ticks and Asian longhorned ticks for two months
To learn more about Bravecto and Bravecto Plus for Cats and the products innovative flea and tick treatment abilities, visit us.bravecto.com.
About BRAVECTO®
Since its introduction in 2014, BRAVECTO has provided longer-lasting flea and tick protection, with more than 250 million doses distributed in 85 countries over eight years. BRAVECTO is available in a variety of formulations, including products for both dogs and cats.
The flea lifecycle can last as long as 12 weeks, and monthly treatments may leave gaps in protection. Providing pets with continuous flea and tick protection is essential – whether the pet goes outside or not. Contrary to popular belief among pet owners, fleas and ticks are not only active in the spring and summer months and are a year-round risk. Fleas and ticks can easily latch onto dogs and cats, and can spread serious diseases, Fleas are the most common external parasite found on pets. BRAVECTO products are only available through licensed veterinarians.
Important Safety Information
BRAVECTO Topical Solution for Cats: The most commonly reported adverse reactions include vomiting, itching, diarrhea, hair loss, decreased appetite, lethargy, and scabs/ulcerated lesions. BRAVECTO Topical Solution for Cats is not effective against American dog ticks beyond 8 weeks of dosing. BRAVECTO Topical Solution has not been shown to be effective for 12-weeks’ duration in kittens less than 6 months of age.
BRAVECTO PLUS Topical Solution for Cats: The most commonly reported adverse reactions include vomiting, hair loss, itching, diarrhea, lethargy, dry skin, elevated ALT, and hypersalivation. BRAVECTO PLUS has not been shown to be effective for 2 months in kittens less than 6 months of age. Use with caution in cats that are heartworm positive. The effectiveness of BRAVECTO PLUS to prevent heartworm disease after bathing or water immersion has not been evaluated. BRAVECTO Topical Solution for Cats and BRAVECTO PLUS for cats are for topical use only. Avoid oral ingestion. The safety of BRAVECTO Topical Solution for Cats and BRAVECTO PLUS have not been established in breeding, pregnant, and lactating cats.
All BRAVECTO products contain fluralaner, which is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Neurologic adverse reactions have been reported in cats receiving isoxazoline class drugs, even in cats without a history of neurologic disorders. Use with caution in cats with a history of neurologic disorders.
About Merck Animal Health
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than a century, we’ve been at the forefront of research, bringing forward medicines, vaccines and innovative health solutions for the world’s most challenging diseases. Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is the global animal health business unit of Merck. Through its commitment to The Science of Healthier Animals®, Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of connected technology that includes identification, traceability and monitoring products. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com or connect with us on LinkedIn, Facebook, and Twitter at @MerckAH.
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