Merck Animal Health Announces FDA Approval of BRAVECTO™ (fluralaner)
First Chewable Tablet for Dogs Effective for 12 Weeks* Against Fleas and Ticks
Tuesday, May 20, 2014 8:15 am EDT
"Effective flea and tick control used regularly is a crucial part of a pet's overall health regimen"
Merck Animal Health (known as MSD Animal Health outside the United States and Canada) today announced the U.S. Food and Drug Administration's approval of BRAVECTO™ (fluralaner) chewable tablets for dogs (112.5 mg, 250 mg, 500 mg, 1000 mg, 1400 mg). BRAVECTO is the first and only treatment that has been shown to quickly and effectively kill fleas and multiple tick species for 12 weeks in a single dose. BRAVECTO also is effective for eight weeks against Amblyomma americanum ticks.
"BRAVECTO is a breakthrough innovation that offers pet owners and veterinarians something that no other product does – the longest-lasting oral flea and tick prevention currently available," said KJ Varma, Senior Vice President, Research and Development, Merck Animal Health. "The approval of BRAVECTO is truly a reflection of our 70-year history of innovation, research and commitment to helping shape the future of animal health, as well as our dedication to bringing novel products to market that meet the evolving needs of pet owners, customers and the industry."
BRAVECTO comes in a convenient, single-dose chewable tablet and offers:
Immediate and persistent flea (Ctenocephalides felis) killing activity for 12 weeks
Immediate and persistent tick killing activity for 12 weeks (Ixodes scapularis – black-legged tick, Dermacentor variabilis – American dog tick, and Rhipicephalus sanguineus – brown dog tick)
Immediate and persistent tick killing activity for 8 weeks (Amblyomma americanum – lone star tick)
"Effective flea and tick control used regularly is a crucial part of a pet's overall health regimen," said Kathleen Heaney, D.V.M., Director of Technical Services, companion animals, Merck Animal Health. "BRAVECTO offers pet owners an easy-to-administer chewable product that is fast-acting and lasts nearly three times longer* than conventional, monthly flea and tick products."
The active substance of BRAVECTO, fluralaner, a new ectoparasiticide belonging to the isoxazoline group, is systemically active against fleas and ticks. BRAVECTO is presented as a flavored chew that dogs accept readily. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD) as a direct result of eliminating flea infestations. The most common side effects are mild and transient gastrointestinal effects.
BRAVECTO is available only through licensed veterinarians.
*BRAVECTO is effective for eight weeks against Amblyomma americanum ticks.
IMPORTANT SAFETY INFORMATION: The most common adverse reactions recorded in clinical trials were vomiting, decreased appetite, diarrhea, lethargy, polydipsia, and flatulence. Bravecto has not been shown to be effective for 12-weeks' duration in puppies less than 6 months of age. Bravecto is not effective against lone star ticks beyond 8 weeks after dosing.
BRAVECTOTM is a trademark of Merck Animal Health, Summit N.J., USA
About Merck Animal Health
Today's Merck is a global healthcare leader working to help the world be well. Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck (NYSE: MRK). Through its commitment to the Science of Healthier Animals™, Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. 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 or connect with us on Twitter.
Merck Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
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