MSD Animal Health Receives Marketing Approval from European Medicines Agency for BRAVECTO™ (fluralaner) Spot-On Solution for Cats and Dogs
May 24, 2016 5:19 am ET
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.
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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
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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
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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
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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
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BRAVECTO™ is a trademark of Intervet International B.V., a subsidiary
of Merck & Co., Inc., Kenilworth, NJ, USA.