Merck Animal Health announced that the U.S. Food and Drug Administration has approved BRAVECTO QUANTUM (fluralaner for extended-release injectable suspension), marking the first parasiticide to provide year-long flea and tick protection for dogs with a single injection. The product is expected to be available at veterinary clinics and hospitals nationwide by August 2025.
Global Approval and Market Presence
BRAVECTO QUANTUM was first approved in Australia and New Zealand in 2023, followed by the European Union in 2024, and now the U.S. in 2025. The product is currently approved in more than 50 countries worldwide, demonstrating its global acceptance in veterinary medicine.
"We take great pride in our company's leadership in long-acting preventative parasiticides and are excited to offer a convenient option that gives dogs year-round comprehensive protection from fleas and ticks in one easy injection they can receive from their veterinarian," said Christine Royal, DVM, vice president, companion animal and equine business unit, Merck Animal Health.
Clinical Indications and Efficacy
BRAVECTO QUANTUM kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and for the treatment and control of tick infestations for 12 months in dogs and puppies 6 months of age and older. The product provides protection against Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick) for the full 12-month duration.
However, BRAVECTO QUANTUM is indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for only 8 months in dogs and puppies 6 months of age and older.
Unique Formulation and Market Position
The product utilizes a unique, patented composition of fluralaner that allows effective levels to be maintained for as long as 12 months. According to Frank Guerino, Ph.D., associate vice president of Global Pharmaceutical Development at Merck Animal Health, "With BRAVECTO QUANTUM, a single dose provides year-long, continuous protection, simplifying care for both pet owners and veterinarians, and promoting compliance."
BRAVECTO QUANTUM is positioned as the first and only parasiticide that protects against fleas and ticks for an entire year with a single dose, offering longer flea and tick protection than any other systemic product currently on the market.
Safety Profile and Precautions
The most commonly reported adverse reactions in a U.S. field study included lethargy, decreased appetite, vomiting, diarrhea, elevated liver enzymes, and pruritus. Fluralaner belongs to the isoxazoline class, which 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.
The product should be used with caution in dogs with a history of seizures or neurologic disorders. The safety of BRAVECTO QUANTUM has not been evaluated in breeding, pregnant, and lactating dogs.
BRAVECTO Brand Legacy
Since its introduction in 2014, the BRAVECTO brand has provided longer-lasting flea and tick protection, with more than 350 million doses distributed in 100 countries over eight years. The brand is available in various formulations for both dogs and cats.
BRAVECTO QUANTUM has been recognized as a winner of the 2024 Edison Awards and the 2024 S&P Global Awards for Best New Companion Animal Product, highlighting its innovation in veterinary parasiticide development.
