17 February 2014
Merck Animal Health Receives Marketing Authorization from European Commission for BRAVECTO™ (fluralaner)
First Chewable Tablet Approved for Fleas and Ticks in Dogs Effective For 12 Weeks
(8 weeks forRhipicephalus sanguineus ticks)
SUMMIT, N.J., February 17, 2014 – Merck Animal Health (known as MSD Animal Health outside the United States and Canada) today announced that, following a positive opinion from the Committee for Medicinal Products for Veterinary Use (CVMP), the European Commission has granted the marketing authorization for the veterinary medicinal product BRAVECTO™ (fluralaner) chewable tablets for dogs (112.5 mg, 250 mg, 500 mg, 1000 mg, 1400 mg). This is the first and only treatment that has been shown to quickly and effectively kill fleas and ticks for up to 12 weeks in a single dose.*
“BRAVECTO provides a powerful new weapon in the fight against these dangerous parasites,” said KJ Varma, Senior Vice President, Research & Development, Merck Animal Health. “We are incredibly proud to bring this new innovative chewable tablet to dog owners which we could not have done without the partnership of the clinical veterinarians who worked with us to bring this advancement to market.”
BRAVECTO is indicated for the treatment of tick and flea infestation on dogs. It is a systemic insecticide and acaricide that provides*:
- Immediate and persistent flea (Ctenocephalides felis) killing activity for 12 weeks
- Immediate and persistent tick killing activity for 12 weeks (Ixodes ricinus, Dermacentor reticulatus and Dermacentor variabilis)
- Immediate and persistent tick killing activity for 8 weeks (Rhipicephalus sanguineus)
“We are delighted with the CVMP’s decision to grant marketing authorization for BRAVECTO,” said David Hallas, Associate Vice President, Merck Animal Health. “Now veterinarians and pet owners have a highly effective treatment option that works quickly and lasts longer than the currently available once-monthly treatment options.”
The active substance of BRAVECTO, fluralaner, a new ectoparasiticide belonging to the isoxazoline group, is systemically active against fleas and ticks. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatits (FAD). The most common side effects are mild and transient gastrointestinal effects.
BRAVECTO will be launched in Germany, Spain, Italy, France, The Netherlands and the United Kingdom in April 2014. It will be introduced in additional European countries in the coming months.
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. 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.
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