BRAVECTO PLUS for Cats Receives FDA Approval

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Press release: Merck Animal Health

Merck Animal Health, a division of Merck & Co. Inc. in Kenilworth, New Jersey, announced November 15 the U.S. approval of BRAVECTO PLUS topical solution for cats by the U.S. Food and Drug Administration (FDA). BRAVECTO PLUS is an extended-duration, broad-spectrum combination (fluralaner and moxidectin) topical solution for cats, indicated for both external and internal parasite infestations: ticks and fleas, heartworm, intestinal roundworm and hookworm. This unique formula in BRAVECTO PLUS provides extended protection for up to two months with just one application, making it the only product on the market to protect against this combination of parasites at a longer duration. BRAVECTO PLUS is expected to be available in the coming months.

“BRAVECTO PLUS addresses five of the top parasite concerns among veterinarians and cat owners, including ticks, fleas, heartworms, roundworms and hookworms,” said Christine Royal, DVM, director, professional services at Merck Animal Health. “These parasites are not just a nuisance, but also pose animal and human health risks. Ticks and fleas can transmit disease; and heartworm disease, transmitted by mosquitoes, is a serious, progressive disease that often goes undiagnosed in cats. We are pleased to offer cat owners the latest innovation from the BRAVECTO family.”

“With BRAVECTO PLUS for cats, we have expanded our portfolio in the fight against parasites by creating an extended duration formulation, ensuring pets receive the broad-spectrum parasite coverage,” Dr. Royal said.

BRAVECTO PLUS contains fluralaner (280 mg/mL), an ectoparasiticide which has systemic activity against ticks and fleas, and moxidectin (14 mg/mL), an endectocide which has systemic activity against a range of external and internal parasites.

BRAVECTO PLUS treats fleas and ticks fast, killing 100 percent of fleas and more than 99.7 percent of ticks in the first 12 hours after the product is applied. This protection works quickly and lasts. Additionally, roundworm is the most common feline intestinal parasite, affecting up to 75 percent of cats, and is also effectively treated with BRAVECTO PLUS. The quality of extended-duration treatment with BRAVECTO PLUS helps to improve compliance among pet owners, which may lead to healthier cats.

BRAVECTO PLUS is part of the Merck Animal Health pet health portfolio, which includes Sure Petcare, a range of digitally connected products.

Important safety information about BRAVECTO PLUS spot-on 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. For topical use only. Avoid oral ingestion. The safety of BRAVECTO PLUS has not been established in breeding, pregnant and lactating cats. Fluralaner is a member of the isooxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Neurologic adverse reactions have been reported in cats receiving isooxazoline class drugs, even in cats without a history of neurologic disorders. Use with caution in cats with a history of neurologic disorders. 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 be evaluated.

About BRAVECTO PLUS

BRAVECTO PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati; 4th stage larvae, immature adults and adults) and hookworm (Ancylostoma tubaeforme; 4th stage larvae, immature adults and adults). BRAVECTO PLUS kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Ixodes scapularis; black-legged tick) and Dermacentor variabilis; (American dog tick)] for two months in cats and kittens 6 months of age and older and weighing 2.6 pounds or greater.

About BRAVECTO (fluralaner)

Since its introduction in 2014, BRAVECTO has provided longer-lasting flea and tick protection, with more than 100 million doses distributed in 85 countries over five 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. One treatment with BRAVECTO lasts 12 weeks, protects almost three times longer than monthly treatments and is proven to kill fleas on dogs and cats and to eliminate them from the home.

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, including tapeworms and lyme disease. They also can bite and pose health risks to human family members whether at home or outdoors. Fleas are the most common external parasite found on pets.

BRAVECTO products are only available through licensed veterinarians.

BRAVECTO has not been shown to be effective for 12 weeks’ duration in puppies or kittens less than 6 months of age.

BRAVECTO Chew: The most commonly reported adverse reactions include vomiting, decreased appetite, diarrhea, lethargy, polydipsia and flatulence. BRAVECTO is not effective against lone star ticks beyond eight weeks of dosing.

BRAVECTO Topical Solution for Dogs: The most commonly reported adverse reactions include vomiting, hair loss, diarrhea, lethargy, decreased appetite and moist dermatitis/rash. BRAVECTO is not effective against lone star ticks beyond 8 weeks of dosing. For topical use only. Avoid oral ingestion. Use caution in dogs with a history of seizures. Seizures have been reported in dogs receiving fluralaner, even in dogs without a history of seizures.

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 is not effective against American dog ticks beyond eight weeks of dosing. For topical use only. Avoid oral ingestion. The safety of BRAVECTO has not been established in breeding, pregnant and lactating cats. Use with caution in cats with a history of neurologic abnormalities. Neurologic abnormalities have been reported in cats receiving BRAVECTO, even in cats without a history of neurologic abnormalities.