Merck Animal Health Receives U.S. FDA Approval of Expanded Indication for BRAVECTO (fluralaner) Chews for Dogs
Portfolio expansion provides dogs broad-spectrum protection against Asian longhorned ticks
BRAVECTO Chews for Dogs is the first and only
“The approval of this additional BRAVECTO use builds on the strong foundation and body of scientific evidence that we have established over the years with our broad-spectrum comprehensive line of parasite protection products,” said
BRAVECTO Chews for dogs is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), treatment and control of tick infestations (Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Rhipicephalus sanguineus (brown dog tick)] and Haemaphysalis longicornis (Asian longhorned tick) for 12 weeks and treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks.
“Parasites pose serious animal and human health risks as fleas and ticks can transmit disease agents,” said
BRAVECTO Chews for Dogs is part of the
BRAVECTO Chews for Dogs is available in five strengths (112.5, 250, 500, 1000, and 1400 mg fluralaner) per chew. To learn more about BRAVECTO and our innovative flea and tick treatments, visit us.bravecto.com.
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 1-MONTH Chews: indicated for dogs 8 weeks of age and older. The most commonly reported adverse reactions include itching, diarrhea, vomiting, decreased appetite, elevated ALT, lethargy, and weight loss. BRAVECTO 1-MONTH is not effective against A. americanum in puppies less than 6 months of age. BRAVECTO Chews for Dogs: The most commonly reported adverse reactions include vomiting, lethargy, diarrhea, anorexia and pruritus. In some cases, adverse events have been reported following use in breeding females. BRAVECTO Topical Solution for Dogs: The most commonly reported adverse reactions include vomiting, hair loss, diarrhea, lethargy, decreased appetite, and moist dermatitis/rash. 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 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 has not been shown to be effective for 12-weeks’ duration in puppies or kittens less than 6 months of age. BRAVECTO Chews and Topical Solution for dogs is not effective against the lone star tick beyond 8 weeks of dosing. BRAVECTO Topical Solution for Dogs and 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 has 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. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. 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.
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Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended
Raghaven et al (Potential Spatial Distribution of the Newly Introduced Long-horned Tick, Haemaphysalis longicornis in
United States Department of Agriculture (USDA) National Haemaphysalislongicornis (Asian longhorned tick) Situation Report.
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