FDA Approves BRAVECTO® QUANTUM (Fluralaner for Extended-Release Injectable Suspension) from Merck Animal Health

Business Wire

10-07-2025

RAHWAY, N.J.--(BUSINESS WIRE)--Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced the U.S. Food and Drug Administration (FDA) approval of BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) – a new, once-yearly1 injectable product to treat and protect dogs from fleas and ticks. The product is expected to be available at veterinary clinics and hospitals nationwide by August 2025.
BRAVECTO QUANTUM was first approved in Australia and New Zealand in 2023, followed by the European Union (EU) in 2024 and now the U.S. in 2025. In total, BRAVECTO QUANTUM is currently approved in more than 50 countries worldwide.
'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-round1 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. 'The approval of BRAVECTO QUANTUM sets a new standard in pet care by providing veterinarians and pet parents with a safe and effective option when it comes to flea and tick protection for dogs.'
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 – Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick) and Rhipicephalus sanguineus (brown dog tick) for 12 months in dogs and puppies 6 months of age and older. BRAVECTO QUANTUM is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 months in dogs and puppies 6 months of age and older.
BRAVECTO QUANTUM is 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.
'Though people often think of flea and tick season during the summer months, studies have shown that while fleas and ticks are most active from early spring through the fall, they can be a threat year-round, especially knowing it only takes a few warm days for ticks to become active,' said Frank Guerino, Ph.D., associate vice president of Global Pharmaceutical Development, 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 utilizes a unique, patented composition of fluralaner that allows effective levels to be maintained for as long as 12 months. Fleas and ticks are a nuisance and pose serious risk to both animal and human health as they can transmit serious diseases. Fleas can also cause severe allergic dermatitis in dogs and cats. Many fleas and ticks can live in both warm and cold temperatures, making continuous year-round protection of utmost importance for pets and people.
BRAVECTO QUANTUM exemplifies Merck Animal Health's commitment to groundbreaking science and has been recognized as a winner of the 2024 Edison Awards and the 2024 S&P Global Awards for Best New Companion Animal Product. For more information, visit us.bravecto.com or follow BRAVECTO on Instagram @bravecto.us.
1 BRAVECTO® QUANTUM is indicated to protect against Amblyomma americanum for 8 months.
About BRAVECTO®
Since its introduction in 2014, BRAVECTO has provided longer-lasting flea and tick protection, with more than 350 million doses distributed in 100 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 QUANTUM: indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and for the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick) and Rhipicephalus sanguineus (brown dog tick)] for 12 months in dogs and puppies 6 months of age and older. BRAVECTO QUANTUM is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 months in dogs and puppies 6 months of age and older. BRAVECTO QUANTUM (fluralaner for extended-release injectable suspension) for Dogs: The most commonly reported adverse reactions in a US field study included lethargy, decreased appetite, vomiting, diarrhea, elevated liver enzymes and pruritus. BRAVECTO QUANTUM is not effective against lone star ticks beyond 8 months of dosing. Fluralaner 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. The safety of BRAVECTO QUANTUM has not been evaluated in breeding, pregnant and lactating dogs. In some cases, adverse events have been reported following use of BRAVECTO (fluralaner) Chews in breeding females. For use in dogs and puppies 6 months of age and older.
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.
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 of Merck. Through its commitment to The Science of Healthier Animals®, Merck Animal Health offers veterinarians, farmers, producers, 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 and connect with us on LinkedIn, Facebook, X (formerly Twitter) and Instagram.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
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 pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
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 December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).