Merck Animal Health Receives U.S. FDA Approval of BRAVECTO Monthly Chews

July 9, 2020 – Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Kenilworth, N.J., USA [NYSE: MRK], today announced the U.S. Food and Drug Administration’s approval of BRAVECTO® 1-MONTH (fluralaner) Chews for dogs and puppies 8 weeks of age and older. The product is administered as a single, monthly flavored chew formulation for treatment and prevention of fleas and treatment and control of ticks. BRAVECTO 1-MONTH is expected to be available in the coming months.

BRAVECTO 1-MONTH is an important addition to the company’s parasiticide portfolio, which are extended duration flea and tick protection products that offer broad-spectrum, comprehensive parasite protection for dogs. This new product is suitable for dogs in the early stages of life to begin a regimen of monthly flea and tick protection. Pet owners now can begin their dog’s early life experience on this monthly product and have the option to easily transition to the extended duration BRAVECTO products as the dog reaches 6 months of age, helping to ensure consistent treatment and compliance.

“The approval of this additional BRAVECTO product 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 KJ Varma, BVSc, PhD, senior vice president, Research and Development, Merck Animal Health. “With BRAVECTO 1-MONTH, we have expanded our portfolio with a superior advance in the fight against parasites, as well as provided both adult dogs and puppies with flea and tick protection that delivers immediate and persistent killing activity.”

BRAVECTO 1-MONTH 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), Dermacentor variabilis (American dog tick) and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs and puppies 8 weeks of age and older and weighing 4.4 pounds or greater. BRAVECTO 1-MONTH is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for one month in dogs and puppies 6 months of age and older and weighing 4.4 pounds or greater.

“Parasites pose serious animal and human health risks as fleas and ticks can transmit disease,” said Christine Royal, DVM, executive director, U.S. Companion Animal and Equine Professional Services, Merck Animal Health. “Effective protection against these parasites is essential to safeguard our pets as well as our homes. The approval of BRAVECTO 1-MONTH is an ideal start for dogs in the early stages of life with the benefit of a tasty, monthly chew formulation that is fast-acting and efficacious.”

BRAVECTO 1-MONTH contains fluralaner, an ectoparasiticide belonging to the isoxazoline class, which has systemic activity against ticks and fleas. The product is available in five strengths (45, 100, 200, 400 and 560 mg) per chew.

BRAVECTO 1-MONTH is part of the Merck Animal Health companion animal portfolio, which includes Sure Petcare, a range of digitally connected products, as well as a broad range of veterinary medicines and vaccines.

On July 2, 2020, Merck Animal Health announced the completion of its product acquisition for the U.S. rights to SENTINEL® FLAVOR TABS® and SENTINEL® SPECTRUM® Chews in the Companion Animal category. Comprehensive parasite protection is an essential part of canine overall health and well-being. The BRAVECTO product line, which are our extended duration flea and tick protection products, and the SENTINEL branded products, which control all common intestinal parasites, provide broad-spectrum, year-round comprehensive internal and external parasite protection for dogs. These complementary products will cover the seven common, harmful parasites that affect dogs inside and out by preventing ticks and multiple stages of the flea lifecycle, including eggs and adult fleas, as well as treating and controlling all common intestinal parasites, including roundworms, hookworms, whipworms and tapeworms and preventing heartworm disease.