Merck Animal Health Receives FDA Approval of BRAVECTO® (fluralaner topical solution) for Cats and Dogs
Topical Treatment for Fleas and Ticks Effective for up to 12 Weeks
MADISON, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck Animal Health, known as MSD Animal Health outside of the United
States and Canada, today announced the U.S. Food and Drug
Administration’s approval of BRAVECTO® (fluralaner topical
solution) for both cats and dogs, a topical treatment for fleas and
ticks effective for up to 12 weeks1,2 following a single dose.
“The approval of a second BRAVECTO product builds on the strong
foundation and body of scientific evidence that we have established with
our chewable tablet for dogs, our oral flea and tick product,” said KJ
Varma, senior vice president, research and development, Merck Animal
Health. “With BRAVECTO Topical, we have expanded our portfolio in the
fight against parasites, as well as provided cats flea and tick
protection that delivers immediate and persistent killing activity for
12 weeks – another first in the industry.”
BRAVECTO Topical is available in a convenient, single-dose spot-on, and
is applied topically using the new “Twist’n’Use”TM pipette
design for ease of application. BRAVECTO Topical for dogs kills adult
fleas and is indicated for the treatment and prevention of flea
infestations (Ctenocephalides felis) and 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 weeks in dogs and puppies six
months of age and older, and weighing 4.4 pounds or greater. It is also
indicated for the treatment and control of Amblyomma americanum (lone
star tick) infestations for eight weeks in dogs and puppies six months
of age and older, and weighing 4.4 pounds or greater.
BRAVECTO Topical for cats kills adult fleas and is indicated for the
treatment and prevention of flea infestations (Ctenocephalides felis)
and the treatment and control of Ixodes scapularis (black-legged
tick) infestations for 12 weeks in cats and kittens six months of age
and older, and weighing 2.6 pounds or greater. It is also indicated for
the treatment and control of Dermacentor variabilis (American dog
tick) infestations for eight weeks in cats and kittens six months of age
and older and weighing 2.6 pounds or greater.
“Fleas and ticks are not simply a nuisance, but can also cause
significant irritation to our pets and even ourselves, and can transmit
disease. So, effective protection against these parasites is truly
essential to the health and well-being of our pets, as well as our
homes,” said Kathleen Heaney, D.V.M., executive director of technical
services, Merck Animal Health. “The convenience of BRAVECTO’s extended
duration flea and tick protection is now available for cats and dogs in
a topical formulation that is fast-acting and lasts nearly three times
longer than conventional, monthly flea and tick products.”1,2
Fleas and ticks must attach to the treated animal and commence feeding
in order to be exposed to the active substance. The active substance of
BRAVECTO, fluralaner, an 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
Dermatitis (FAD) as a direct result of eliminating flea infestations.
BRAVECTO products are only available through licensed veterinarians.
BRAVECTO Topical for cats is expected to be available later in 2016. The
dog topical product is expected to be available in the first quarter of
2017.
Important Safety Information (Cats):
The most common adverse reactions recorded in clinical trials were
vomiting, itching, diarrhea, hair loss, decreased appetite, lethargy,
and scabs/ulcerated lesions. Bravecto has not been shown to be effective
for 12-weeks’ duration in kittens less than 6 months of age. Bravecto is
not effective against American dog ticks beyond 8 weeks of dosing. For
topical use only. Avoid oral ingestion. The safety of Bravecto has not
been established in breeding, pregnant and lactating cats. Use with
caution in cats with a history of neurologic abnormalities. Neurologic
abnormalities have been reported in cats receiving Bravecto, even in
cats without a history of neurologic abnormalities.
Important Safety Information (Dogs):
The most common adverse reactions recorded in clinical trials were
vomiting, hair loss, diarrhea, lethargy, decreased appetite, and moist
dermatitis/rash. 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 of dosing. For topical
use only. Avoid oral ingestion. Use with caution in dogs with a history
of seizures. Seizures have been reported in dogs receiving fluralaner,
even in dogs without a history of seizures.
Click to view the U.S. Prescribing Information for BRAVECTO Topical
Solution for cats
and BRAVECTO Topical Solution for dogs.
About Merck Animal Health
For 125 years, Merck has been a global health care 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 LinkedIn and
Twitter at @MerckAH.
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“company”) includes “forward-looking statements” within the meaning of
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1 BRAVECTO Topical for cats is not effective against Dermacentor
variabilis ticks beyond 8 weeks after dosing.
2 BRAVECTO Topical for dogs is not effective against Amblyomma
americanum ticks beyond 8 weeks after dosing.
Contacts
Merck Animal Health
Media:
Kelly Goss, 913-558-6452
kelly.goss@merck.com
or
Pamela
Eisele, 267-305-3558
pamela.eisele@merck.com
or
Investor
Relations:
Amy Klug, 908-740-1898
amy.klug@merck.com
