MSD Animal Health Receives Marketing Approval from European Medicines Agency for BRAVECTO™ (fluralaner) Spot-On Solution fo...
May 24 2016 - 6:19AM
Business Wire
Spot-On Treatment for Fleas and Ticks
Effective For 12 Weeks
MSD Animal Health (known as Merck Animal Health in the United
States and Canada) today announced that, following a positive
opinion from the Committee for Medicinal Products for Veterinary
Use (CVMP), the European Medicine Agency has granted a marketing
authorization for the veterinary medicinal product BRAVECTO™
(fluralaner) Spot-On Solution for both cats and dogs, a Spot-On
treatment for fleas and ticks effective for 12 weeks following a
single dose.
BRAVECTO Spot-On, a systemic insecticide and acaricide, is
indicated for the treatment of tick and flea infestations on cats
and dogs and provides immediate and persistent flea and tick
killing activity for 12 weeks. BRAVECTO Spot-On is applied
topically using the new “Twist’n’Use”™ pipette design for ease of
application. Detailed conditions of the product will be described
in the summary of product characteristics (SPC) which will be
published in the European public assessment report (EPAR).
“Approval of BRAVECTO Spot-On builds on the strong foundation
and body of scientific evidence that we have established with our
chewable tablet for dogs, the oral flea and tick product available
today,” said KJ Varma, senior vice president, research &
development, MSD Animal Health. “BRAVECTO Spot-On now provides
veterinarians and cat owners another tool in the fight against
parasites and gives veterinarians and dog owners a choice in how to
administer flea and tick protection that works quickly and lasts up
to twelve weeks.”
In 2014, BRAVECTO was launched as a chewable tablet for dogs.
More than 13 million doses of the BRAVECTO chew have been dispensed
in 60 countries since its introduction.
Fleas and ticks must attach to the treated animal and commence
feeding in order to be exposed to the active substance. The most
common side effects of BRAVECTO Spot-On in dogs are mild and
transient skin reactions such as erythema or alopecia at the
application site and, in cats, pruritus at the application site.
The product can be used as part of a treatment strategy for the
control of Flea Allergy Dermatitis (FAD). The most common side
effects of BRAVECTO chewable tablet administration to dogs are mild
and transient gastrointestinal effects.
BRAVECTO Spot-On will be available in countries throughout
Europe in the coming months. Veterinarians interested in learning
more about BRAVECTO Spot-On should contact their MSD Animal Health
representative.
About MSD Animal Health
For 125 years, MSD has been a global health care leader working
to help the world be well. MSD Animal Health, known as Merck Animal
Health in the United States and Canada, is the global animal health
business unit of MSD. Through its commitment to the Science of
Healthier Animals™, MSD Animal Health offers veterinarians,
farmers, pet owners and governments one of the widest range of
veterinary pharmaceuticals, vaccines and health management
solutions and services. MSD 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. MSD Animal
Health is present in more than 50 countries, while its products are
available in some 150 markets. For more information, visit
www.msd-animal-health.com or connect with us on LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, 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 products that
the products 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 2015
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
BRAVECTO™ is a trademark of Intervet International B.V., a
subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
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version on businesswire.com: http://www.businesswire.com/news/home/20160524005836/en/
MSD Animal HealthMedia:Amy Firsching, +1 973 937
5453amy.firsching@merck.comorPam Eisele,
267-305-3558pamela_eisele@merck.com
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