Latest news with #MSDAnimalHealth
Agriland
04-08-2025
- Health
- Agriland
Cryptosporidiosis vaccine tackles calving season challenge for Co. Down farmer
Bovilis Cryptium vaccine from MSD Animal Health protects calves from crypto scour. When Beattie Lilburn experienced his first case of cryptosporidiosis scour during calving last November, he knew prompt action was required to protect his calves. Acting quickly on veterinary advice, Beattie turned to Bovilis Cryptium, the cryptosporidiosis vaccine from MSD Animal Health, to help bring the outbreak under control. Beattie, along with his wife Margaret and sons David and Reggie, run a 280-cow Holstein herd at Hillcrest Farm near Lisburn, Co. Down. The family farms approximately 300ac of grassland, 200ac of combinable crops, and 35ac of beans, with calving taking place between September 1 and the end of March. Beattie recalls how quickly things changed on the farm. He said: 'We had about 50 cows left to calve when the crypto outbreak hit last November. We'd never had a problem with it previously, but we knew we had to deal with it as quickly as possible.' Beattie said he immediately contacted his vet, Joy Crawford from Lisburn Vets, who gave him advice and recommended Bovilis Cryptium. 'We wasted no time getting started – we vaccinated the 50 cows that were still due to calve." "For the calves already affected, we gave an oral drench once a day for seven consecutive days to manage the scour, as well as using a strict hygiene and disinfection protocol for the calving pens and calf shed. "After that, the rest of the calves arrived safely and we had no further problems," Beattie said. Bovilis Cryptium is the first and only vaccine to protect calves against cryptosporidiosis. It works by raising specific antibodies in the cow before calving, which are passed to the calf through colostrum and transition milk when fed for a minimum of five days. This provides the calf with passive immunity against Cryptosporidium parvum during the first two weeks of life, when they are most vulnerable to the disease. The primary course of Bovilis Cryptium consists of two doses of 2ml, given under the skin, four to five weeks apart. These vaccinations must be completed between 12 and three weeks before calving. After that, a single booster dose is given 12 to three weeks before each subsequent calving. Beattie said: 'We'll be starting to dry off in July, and we'll be vaccinating the rest of the herd so that everything is covered for the upcoming calving season. "The 50 cows we vaccinated back in November with the primary course will just need their booster vaccine, while the remaining 230 cows and heifers will receive the full two dose primary course.' Beattie also vaccinates his herd with Bovilis Rotavec Corona, a single dose vaccination given to the cow 12 to three weeks before calving to passively provide protection to calves from diarrhoea caused by rotavirus, coronavirus and E. coli via adequate colostrum and transition milk feeding. Bovilis Rotavec Corona can conveniently be given on the same day as Bovilis Cryptium. The vaccines should be given at different sites. Both vaccines are available in 5, 20 and 50 dose packs and both have a 28-day shelf life once opened. 'While farmers always want to avoid outbreaks, having now faced that situation and dealt with it, we've got great confidence in Bovilis Cryptium after seeing the job it did for us," Beattie said. "I would recommend Bovilis Cryptium to farmers without any hesitation. 'Once we got into calving those cows that we'd vaccinated in November, the problem disappeared – we had no more calves with crypto for the rest of the season." The Co. Down farmer said that using Bovilis Cryptium on the advice of his vet "really helped bring everything back into line for us". He added: 'The old saying still applies, prevention is better than cure. The hassle created by calves scouring during the middle of the calving season remains the nightmare scenario because it's so difficult to clear up. "Given that most of our calving happens between September and the end of December, we're naturally keen to avoid any outbreak of disease during such a tight timeframe. "After what we had to deal with in November, Bovilis Cryptium whole herd vaccination was an easy decision to make." The management of calf scour on farm requires a multifactorial approach with adequate colostrum management, hygiene, nutrition and husbandry being essential in reducing the risk of disease. Speak to your veterinary practitioner for advice on what vaccination and therapeutic options will help to provide the best results on your farm.
Yahoo
10-07-2025
- Health
- Yahoo
FDA Approves BRAVECTO® QUANTUM (Fluralaner for Extended-Release Injectable Suspension) from Merck Animal Health
12-Month Parasiticide Treatment for Dogs Offers Unrivaled Duration of Flea and Tick Protection Compared to Existing Products RAHWAY, N.J., July 10, 2025--(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 or follow BRAVECTO on Instagram @ 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 InformationBRAVECTO 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 HealthAt 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 and connect with us on LinkedIn, Facebook, X (formerly Twitter) and Instagram. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USAThis 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 ( View source version on Contacts Media Contact:Laurel Sawicki(908) Kim Gorode(973) Investor Inquiries:Peter Dannenbaum(908) Sign in to access your portfolio
Business Wire
10-07-2025
- Business
- Business Wire
FDA Approves BRAVECTO ® QUANTUM (Fluralaner for Extended-Release Injectable Suspension) from Merck Animal Health
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-yearly 1 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-round 1 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 or follow BRAVECTO on Instagram @ 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 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 (
Business Wire
10-07-2025
- Business
- Business Wire
FDA Approves BRAVECTO® QUANTUM (Fluralaner for Extended-Release Injectable Suspension) from Merck Animal Health
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 or follow BRAVECTO on Instagram @ 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 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 (
Agriland
01-07-2025
- Health
- Agriland
‘Major concern' as MSD ceases lepto vaccine production
The news that MSD Animal Health has ceased production of a widely-used vaccine for leptospirosis is a 'major concern', according to Ireland's largest farming organisation. Irish Farmers' Association animal health chairperson, TJ Maher has said that farmers are 'now left scrambling to secure an alternative' vaccine. MSD ruminant unit business director, Jack O'Connor has confirmed that the 'difficult decision' has been made to discontinue the production of Bovilis Leptavoid-H. 'Bovilis Leptavoid-H was developed more than 30 years ago, and while this unique vaccine has a strong safety and efficacy profile, it has always proven very difficult to produce, creating recurrent supply challenges,' O'Connor explained. 'Despite multiple years of improvement and remediation efforts, we have not been able to consistently supply the market with a product that meets our quality standards. 'MSD Animal Health is a strong advocate for the important role vaccination plays in reducing the incidence and severity of disease, protecting animal welfare and enabling efficient farming of livestock.' IFA' s TJ Maher said this is going to create a serious issue for farmers who are due to administer a lepto vaccine to their herd in the coming months. 'Reports from our members indicate that there are little alternatives currently available with one of the key alternative vaccines not available until September,' Maher said. 'This could mean that a lot of cattle herds will lose protection from leptospirosis if they miss their annual booster shot.' Vaccine shortages Leptospirosis is a bacterial disease that often leads to reduced milk production, decreased fertility and abortions in cows. It is also a zoonotic disease meaning that humans can potentially pick up the disease from infected animals, which further increases the potential implications of this vaccine shortage. The IFA animal health chairperson outlined that the availability of vaccines when needed is critical for farmers in protecting and maintaining the health, welfare and productivity of animals while reducing antibiotic usage. 'Over the last number of years, farmers have experienced increasing shortages of certain vaccines at critical times and here we are with the same problem yet again,' Maher said. 'Pasteurella vaccine availability have been especially problematic this year.' According to Maher, there have been several special import licences issued for alternative vaccines, but these 'often come too late after supplies have been depleted'. 'The Department of Agriculture must be more proactive in identifying potential supply issues at an early stage and intervene to avoid a situation like we are facing now where farmers may not be able to protect their herd from a potentially very harmful disease,' Maher added. 'These vaccines are too important to animal and human health; we cannot have situations where these vaccines become unavailable to farmers.'
